Osteoporosis New drugs Review
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Osteoporosis New drugs Review
Denosumab is a breakthrough fully human monoclonal antibody approved by both the FDA and EMA in 2010. It had been fast tracked by FDA for treatment and prevention of postmenopausal osteoporosis, treatment and prevention of bone loss in hormone treated prostate and breast cancer patients. The FDA advisory committee (August 13, 2009) to review the safety and efficacy had recommend approval for treatment of high risk bone loss postmenopausal osteoporosis in women and hormone ablation treated men with prostate cancer, with black box warnings for serious side effects and under REMS program. Denosumab may have peak sales in the range of $5 billion within 5 years after approval in US, Europe, Japan and other major markets. New additional indications may follow and it may cross sales of $1 billion in 2012 due to unmet medical need from patients and healthcare providers. Clinical data published and in public domain indicates a superior safety and efficacy profile. FDA has asked for modifications and details of the REMS for treatment of osteoporosis. Denosumab (Prolia, Amgen) after FDA Review was approved under REMS on 1 June 2010. For prevention of osteoporosis and cancer indications, FDA has asked for new studies to show that there was no incidence of increased cancer. Amgen has submitted the BLA for prevention of bone loss in cancer patients on 14 June 2010. FDA had granted it the priority review status and approved the use for reducing fractures and other bone problems in cancer patients on 18 November, 2010. The European Committee for Human Medicinal Products CHMP recommended its approval in December 2009. It was approved by the EMA on 28 may 2010 and was launched there in the 3Q2010. Data presented at the ASCO and ESMO 2010 meetings has been added. The UK cost control agency NICE has recommended the clinical use of Prolia in osteoporosis. Data presented at EULAR showed increased bone density in women taking denosumab for 6 years and significantly reduced risk of fractures in elderly patients. The drug is approved in Switzerland for the prevention of bone loss in breast and prostate cancer patients undergoing hormone therapy besides osteoporosis. Sales of the drug were $33 million in 2010 and peak potential sales of over $ 5 billion per year.
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Denosumab (Prolia, Amgen) FDA Review & Approval - Krishan Maggon

Denosumab (Prolia, Amgen) FDA Review & Approval - Krishan Maggon | Osteoporosis New drugs Review | Scoop.it
Denosumab is a breakthrough fully human monoclonal antibody approved by both the FDA and EMA in 2010. It had been fast...
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NovaBone Bioactive Synthetic Bone Graft

NovaBone Bioactive Synthetic Bone Graft | Osteoporosis New drugs Review | Scoop.it
NovaBone® Dental Putty is 100% synthetic and fully resorbable. It is composed of calcium phosphosilicate (CPS) particles in a bimodal size distribution combined with a polyethylene glycol and glycerine binder. The binder improves handling and aids in maintaining the space between the particles, which facilitates revascularization after implantation. The bioactive CPS component makes up 70% of the putty by volume. Upon implantation, the water soluble binder is absorbed within 24 to 72 hours, creating a 3-dimensional porous scaffold that facilitates diffusion of blood and tissue fluids through the matrix. The smaller CPS particles (32-125 μm) are more rapidly resorbed, providing the initial burst of Ca and P ions. Subsequently, the larger particles (90-710 μm) react, and being more resistant to resorption, continue the process of bone regeneration.

 Osteostimulative & Osteoconductive Unlike most synthetic grafts that are only osteoconductive, bioactive NovaBone® Dental Putty also has an "osteostimulative" effect. After implantation, surface reactions result in absorption of the graft material, a controlled release of Si, Ca, and P ions, and concurrent new bone formation. These surface reactions result in an osteostimulative affect, defined as the stimulation of osteoblast proliferation in vitro as evidenced by increased DNA content and elevated osteocalcin and alkaline phosphatase levels. In vitro gene array analysis has confirmed that when human primary osteoblasts are exposed to extracts of CPS, upregulation of several gene families occurs.
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The effect of bisphosphonate treatment on osteoclast precursor cells in postmenopausal osteoporosis: The TRIO study

The effect of bisphosphonate treatment on osteoclast precursor cells in postmenopausal osteoporosis: The TRIO study | Osteoporosis New drugs Review | Scoop.it
Highlights • Bisphosphonates reduced the population of osteoclast precursor cells. • There is an immediate effect on mature osteoclasts. • There is a later effect on osteoclast precursor cells. • There is no effect on circulating cytokines, RANKL and OPG.
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Evaluating radiocarpal cartilage matrix changes 3-months after anti-TNF treatment for rheumatoid arthritis using MR T1ρ imaging - Ku - 2016 - Journal of Magnetic Resonance Imaging - Wiley Online Li...

Evaluating radiocarpal cartilage matrix changes 3-months after anti-TNF treatment for rheumatoid arthritis using MR T1ρ imaging - Ku - 2016 - Journal of Magnetic Resonance Imaging - Wiley Online Li... | Osteoporosis New drugs Review | Scoop.it
Evaluating radiocarpal cartilage matrix changes 3-months after anti-TNF treatment for rheumatoid arthritis using MR… https://t.co/z2356kwGpN
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Daiichi Sankyo Announces Application in Japan for Additional Indication for Anti-RANKL Antibody, Denosumab | PressReleasePoint

Daiichi Sankyo Announces Application in Japan for Additional Indication for Anti-RANKL Antibody, Denosumab | PressReleasePoint | Osteoporosis New drugs Review | Scoop.it
Tokyo, Japan (September 23, 2016) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has applied for additional indication of denosumab (product name: PRALIA® subcutaneous injection 60mg syringe) for rheumatoid arthritis-related treatment.
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Two-Photon Excitation for Bone Imaging: A New Application for Lanthanide Luminescence 

Two-Photon Excitation for Bone Imaging: A New Application for Lanthanide Luminescence  | Osteoporosis New drugs Review | Scoop.it
In this issue of Chem, Gunnlaugsson and colleagues show that using a luminescent EuIII cyclen complex with a sensitizer capable of two-photon excitation leads to unprecedented in-depth high-resolution imaging of microcracks in bone at a 750 nm excitation wavelength.
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Two-Photon Excitation for Bone Imaging: A New Application for Lanthanide Luminescence Ana de Bettencourt-DiascorrespondencePress enter key for correspondence informationemailPress enter key to Email the author DOI: http://dx.doi.org/10.1016/j.chempr.2016.08.019
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Graphene nanoribbons show promise for healing spinal injuries

Graphene nanoribbons show promise for healing spinal injuries | Osteoporosis New drugs Review | Scoop.it
Graphene nanoribbons show promise for healing spinal injuries
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Romosozumab Treatment in Postmenopausal Women with Osteoporosis — NEJM

Romosozumab Treatment in Postmenopausal Women with Osteoporosis — NEJM | Osteoporosis New drugs Review | Scoop.it

Original Article from The New England Journal of Medicine — Romosozumab Treatment in Postmenopausal Women with Osteoporosis


BACKGROUND Romosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. 


METHODS We enrolled 7180 postmenopausal women who had a T score of –2.5 to –3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months. Secondary end points included clinical (a composite of nonvertebral and symptomatic vertebral) and nonvertebral fractures. 


RESULTS At 12 months, new vertebral fractures had occurred in 16 of 3321 patients (0.5%) in the romosozumab group, as compared with 59 of 3322 (1.8%) in the placebo group (representing a 73% lower risk with romosozumab; P<0.001). Clinical fractures had occurred in 58 of 3589 patients (1.6%) in the romosozumab group, as compared with 90 of 3591 (2.5%) in the placebo group (a 36% lower risk with romosozumab; P=0.008). Nonvertebral fractures had occurred in 56 of 3589 patients (1.6%) in the romosozumab group and in 75 of 3591 (2.1%) in the placebo group (P=0.10). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group than in the placebo group after each group made the transition to denosumab (0.6% [21 of 3325 patients] in the romosozumab group vs. 2.5% [84 of 3327] in the placebo group, a 75% lower risk with romosozumab; P<0.001). Adverse events, including instances of hyperostosis, cardiovascular events, osteoarthritis, and cancer, appeared to be balanced between the groups. One atypical femoral fracture and two cases of osteonecrosis of the jaw were observed in the romosozumab group. 


CONCLUSIONS In postmenopausal women with osteoporosis, romosozumab was associated with a lower risk of vertebral fracture than placebo at 12 months and, after the transition to denosumab, at 24 months. The lower risk of clinical fracture that was seen with romosozumab was evident at 1 year. 


(Funded by Amgen and UCB Pharma; FRAME ClinicalTrials.gov number, NCT01575834.)

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Felicia Cosman, M.D., Daria B. Crittenden, M.D., Jonathan D. Adachi, M.D., Neil Binkley, M.D., Edward Czerwinski, M.D., Serge Ferrari, M.D., Lorenz C. Hofbauer, M.D., Edith Lau, M.D., E. Michael Lewiecki, M.D., Akimitsu Miyauchi, M.D., Cristiano A.F. Zerbini, M.D., Cassandra E. Milmont, Ph.D., Li Chen, Ph.D., Sc.D., Judy Maddox, D.O., Paul D. Meisner, Pharm.D., Cesar Libanati, M.D., and Andreas Grauer, M.D. 

NEJM September 18, 2016

DOI: 10.1056/NEJMoa1607948
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Janssen submits EU application for rheumatoid arthritis drug | Arthritis Tips

Janssen submits EU application for rheumatoid arthritis drug | Arthritis Tips | Osteoporosis New drugs Review | Scoop.it
Janssen has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), a chronic, systemic...
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How Osteoporosis and Menopause are Connected in Women

How Osteoporosis and Menopause are Connected in Women | Osteoporosis New drugs Review | Scoop.it
Menopause and Osteoporosis can effect women at the same time. Learn exactly why you are at risk and what symptoms and signs you should be looking out for.
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Micro-CT in preclinical imaging: bone regeneration in three dimensions

Micro-CT in preclinical imaging: bone regeneration in three dimensions | Osteoporosis New drugs Review | Scoop.it
Guided bone regeneration (GBR) is a procedure that has been used in dental surgery for over 20 years for the treatment of bone loss.
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Therapeutic inhibition of RANK pathway reduces breast cancer recurrence - Scienmag

Therapeutic inhibition of RANK pathway reduces breast cancer recurrence - Scienmag | Osteoporosis New drugs Review | Scoop.it
Credit: IDIBELL
Researchers at the Institute of Biomedical Research of Bellvitge (IDIBELL), led by Dr. Eva Gonzalez-Suarez, have shown that pharmacological and genetic inhibition of signaling pathw..
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Trial to Study Ultra-High Antibiotic Bone Graft Substitute CERAMENT G | Orthopedics This Week

Trial to Study Ultra-High Antibiotic Bone Graft Substitute CERAMENT G | Orthopedics This Week | Osteoporosis New drugs Review | Scoop.it
Trial to Study Ultra-High Antibiotic Bone Graft Substitute CERAMENT G
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FDA Acceptance Of Biologics License Application For Romosozumab (Amgen, UCB)

FDA Acceptance Of Biologics License Application For Romosozumab (Amgen, UCB) | Osteoporosis New drugs Review | Scoop.it
THOUSAND OAKS, Calif. and BRUSSELS, Sept. 26, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.
Krishan Maggon 's insight:
About Romosozumab Romosozumab is an investigational bone-forming monoclonal agent and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
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Interleukin-33 in health and disease : Nature Reviews Immunology : Nature Research

Interleukin-33 in health and disease : Nature Reviews Immunology : Nature Research | Osteoporosis New drugs Review | Scoop.it
Interleukin-33 (IL-33) — a member of the IL-1 family — was originally described as an inducer of type 2 immune responses, activating T helper 2 (TH2) cells and mast cells. Now, evidence is accumulating that IL-33 also potently stimulates group 2 innate lymphoid cells (ILC2s), regulatory T (Treg) cells, TH1 cells, CD8+ T cells and natural killer (NK) cells. This pleiotropic nature is reflected in the role of IL-33 in tissue and metabolic homeostasis, infection, inflammation, cancer and diseases of the central nervous system. In this Review, we highlight the molecular and cellular characteristics of IL-33, together with its major role in health and disease and the potential therapeutic implications of these findings in humans.
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Interleukin-33 in health and disease 
 Foo Yew Liew, Jean-Philippe Girard & Heth Roderick Turnquist 

Nature Reviews Immunology (2016) doi:10.1038/nri.2016.95 Published online 19 September 2016
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Pharmacological inhibition of cathepsin K: A promising novel approach for postmenopausal osteoporosis therapy

Pharmacological inhibition of cathepsin K: A promising novel approach for postmenopausal osteoporosis therapy | Osteoporosis New drugs Review | Scoop.it
Abstract Osteoporosis is a metabolic bone disease that is characterized by heightened state of bone resorption accompanied by diminished bone formation, leading to a reduction of bone mineral density (BMD) and deterioration of bone quality, thus increasing the risk of developing fractures. Molecular insight into bone biology identified cathepsin K (CatK) as a novel therapeutic target. CatK is a lysosomal cysteine protease secreted by activated osteoclasts during bone resorption, whose primary substrate is type I collagen, the major component of organic bone matrix. Available anti-resorptive drugs affect osteoclast survival and influence both resorption and formation of bone. CatK inhibitors are distinct from the existing anti-resorptives as they only target the resorption process itself without impairing osteoclast differentiation and do not interfere with bone formation. An inhibitor of CatK, odanacatib, robustly increased both trabecular and cortical BMD in postmenopausal osteoporosis patients. The phase III fracture prevention trial with odanacatib ended early due to good efficacy and a favorable benefit/risk profile, thus, enhancing the opportunity for CatK as a pharmacological target for osteoporosis. So far, all the inhibitors that reached to the stage of clinical trial targeted active site of CatK to abrogate the entire proteolytic activity of the enzyme in addition to the desired blockage of excessive elastin and collagen degradation, and could thus pose safety concerns with long term use. Identification of selective exosite inhibitors that inhibit CatK’s elastase and/or collagenase activity but do not affect the hydrolysis of other physiologically relevant substrates of CatK would be an improved strategy to inhibit this enzyme.
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Biochemical Pharmacology Volume 117, 1 October 2016, Pages 10–19
Pharmacological inhibition of cathepsin K: A promising novel approach for postmenopausal osteoporosis therapy 
 Kakoli Mukherjeea,  Naibedya Chattopadhyay.

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Amgen/UCB monoclonal antibody Romosozumab reduced spine fractures, increased bone mineral density 

Amgen/UCB monoclonal antibody Romosozumab reduced spine fractures, increased bone mineral density  | Osteoporosis New drugs Review | Scoop.it
Romosozumab dramatically decreased incidence of vertebral fractures in postmenopausal women with osteoporosis.
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Two-Photon Luminescent Bone Imaging Using Europium Nanoagents

Two-Photon Luminescent Bone Imaging Using Europium Nanoagents | Osteoporosis New drugs Review | Scoop.it
Highlights •Synthesis of AuNPs possessing conjugated lanthanide-based Ca(II) targeted ligands •The nanoagents lock onto damaged bone structure, facilitating TPE microscopy imaging •Long-lived AuNP-based Eu(III) emission that overcomes background emission is achieved •2D TPE microscopic (z stack) mapping of damaged bone area is achieved
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Esther M. Surender, Steve Comby, Brenton L. Cavanagh, Orlaith Brennan, T. Clive Lee, Thorfinnur Gunnlaugsson

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TAmiRNA osteomiR test: biomarkers for bone quality and musculoskeletal disease.

TAmiRNA osteomiR test: biomarkers for bone quality and musculoskeletal disease. | Osteoporosis New drugs Review | Scoop.it

TAmiRNA GmbH is a biopharmaceutical R&D company founded to drive the discovery and development of microRNAs (miRNAs) as tools for diagnosis and treatment of age-associated disorders such as Osteoporosis, Cardiovascular Disease and Neurodegenerative Disease.


Highlights osteomiRs are novel biomarker candidates for bone quality and fracture-risk in osteoporosis. They have been identified on the basis of several clinical studies in primary secondary human osteoporosis. See list of publications. One-stop solution: the osteomiRTM (RUO) kit provides all reagents for minimal-invasive detection of 11 osteomiRs and 5 controls in human serum. Fully compatible with standardized data analysis is the key: the osteomiRTM App enables rapid processing of raw data, quality control and normalization for all users.

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Strontium folate loaded biohybrid scaffolds seeded with dental pulp stem cells induce in vivo bone regeneration in critical sized defects - Biomaterials Science (RSC Publishing)

Strontium folate loaded biohybrid scaffolds seeded with dental pulp stem cells induce in vivo bone regeneration in critical sized defects - Biomaterials Science (RSC Publishing) | Osteoporosis New drugs Review | Scoop.it
Strontium folate (SrFO) is a recently developed bone promoting agent with interest in medical and pharmaceutical fields due to its improved features in comparison to current strontium based therapies for osteoporosis and other bone diseases.
Krishan Maggon 's insight:
Marcela Martin-del-Campo,a Raul Rosales-Ibañez, Keila Alvarado, Jose G. Sampedro, Christian A. Garcia-Sepulveda,Sanjukta Deb, Julio San Románg and Luis Rojo

 Biomater. Sci., 2016, Advance Article DOI: 10.1039/C6BM00459H 

First published online 19 Sep 2016
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Amgen/UCB Romosozumab Reductions In New Fractures In Postmenopausal Women With Osteoporosis Phase 3 FRAME Study

Amgen/UCB Romosozumab Reductions In New Fractures In Postmenopausal Women With Osteoporosis Phase 3 FRAME Study | Osteoporosis New drugs Review | Scoop.it
Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clini... https://t.co/4QQUUt6z3i

THOUSAND OAKS, Calif. and BRUSSELS, Sept. 18, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced findings from the FRAME study showing that the investigational agent romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the study's co-primary endpoints. The results from the Phase 3 study, the first to evaluate fracture risk reduction as early as one year as a primary endpoint, were published in the New England Journal of Medicine (NEJM) and presented today in an oral session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Atlanta. Romosozumab works by binding and inhibiting the activity of the protein sclerostin, and as a result, has a dual effect on bone, both increasing bone formation and decreasing bone breakdown.

FRAME Data Simultaneously Published in New England Journal of Medicine and Presented at ASBMR Showed Treatment With Romosozumab Significantly Reduced New Vertebral and Clinical Fractures Through 12 Months 

Significant Bone Mineral Density Gains Shown at Six and 12 Months at the Lumbar Spine, Total Hip and Femoral Neck 

Bone Mineral Density Continued to Increase and Vertebral Fracture Risk Reduction Persisted With the Transition From Romosozumab to Denosumab Through 24 Months
Krishan Maggon 's insight:
About Romosozumab Romosozumab is an investigational bone-forming monoclonal agent and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of the protein sclerostin and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
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Shockwave Medical’s Lithoplasty system gets FDA approval to treat calcified PAD - Medical Devices Business Review

Shockwave Medical’s Lithoplasty system gets FDA approval to treat calcified PAD - Medical Devices Business Review | Osteoporosis New drugs Review | Scoop.it
Shockwave Medical has secured approval from the US Food and Drug Administration (FDA) for its Lithoplasty system to treat calcified plaque in patients
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Stem Cell Causes Calcification of Blood Vessels

Stem Cell Causes Calcification of Blood Vessels | Osteoporosis New drugs Review | Scoop.it
According to the Centers for Disease Control and Prevention, most of the 20 million adults in the United States with chronic kidney disease will die from h
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Feed Molecule to Stem Cells, Get Bone Regeneration | Orthopedics This Week

Feed Molecule to Stem Cells, Get Bone Regeneration | Orthopedics This Week | Osteoporosis New drugs Review | Scoop.it
Feed Molecule to Stem Cells, Get Bone Regeneration
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Monoclonal antibodies for the treatment of osteoarthritis

Monoclonal antibodies for the treatment of osteoarthritis | Osteoporosis New drugs Review | Scoop.it
(2016). Monoclonal antibodies for the treatment of osteoarthritis. Expert Opinion on Biological Therapy. Ahead of Print. doi: 10.1080/14712598.2016.1229774

ABSTRACT 

Introduction: Osteoarthritis (OA) is a multifactorial chronic joint disease, and so far, there are no approved disease-modifying anti-OA drugs (DMOADs). There is an urgent need to develop therapies for different phenotypes of OA. Monoclonal antibodies (mAb) may slow structural progression, control inflammation and relieve pain, and thus have the potential to be DMOADs. 

 Areas covered: In this review, the authors searched the literature on PubMed, EMBASE and the Cochrane Library using keywords, including mAbs, biological agents, OA and osteoarthritis, electronically up to May 2016. They also included abstracts of international conferences. Furthermore, they reviewed experimental and clinical studies of various mAbs targeting different pathological mechanisms of OA, including ADAMTS, Interleukine-1, tumour necrosis factor, never growth factor and vascular endothelial growth factor. 

 Expert opinion: MAbs for the treatment of OA are under intense investigation and the results for some mAbs (e.g., anti-nerve growth factor mAbs, anti- vascular endothelial growth factor mAbs) are promising. The authors believe that mAb therapy can be a targeted therapeutic approach for the treatment of OA. Future clinical trials are required to evaluate the therapeutic efficacy of these agents by the appropriate selection of specific phenotype for targeted therapy based on the mechanism of drug action. KEYWORDS: Inflammation, OA, DMOADs, mAbs,
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Osteoporosis and Smoking Raise Fracture Risk in People With HIV

Osteoporosis and Smoking Raise Fracture Risk in People With HIV | Osteoporosis New drugs Review | Scoop.it
Osteoporosis raised the risk of broken bones 4 times in a study of 1006 middle-aged people with HIV infection in the United States. Smoking raised th
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