Top Selling Monoclonal Antibodies 2014
86.8K views | +4 today
Follow
Top Selling Monoclonal Antibodies 2014
Top Selling Monoclonal Antibodies 2014
Abstract A review of the best selling monoclonal antibodies in 2014 and 2013 is provided. Humira with sales of over $12.7 billion ($9.3 bn in 2012, $11bn 2013) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2014 and since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table.  Remicade (9.8 Bn), Rituxan (7.6 Bn) , Avastin (7.0 Bn) and Herceptin (6.8 Bn)  were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2014 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $68 billion in 2014. The global sales of all the approved therapeutic monoclonal antibodies were $78 billion in 2014. Besides the top 5 mabs, there was two monoclonal antibody with sales of over $3 billions, three with sales over $ 2 billion and 6 with sales of over $ 1 billion in 2014. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 36 monoclonal antibodies are marketed in the US and Europe (January 2015).  FDA approved 6 new monoclonal antibodies in 2014. Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.2 billion in 2014.
Curated by Krishan Maggon
Your new post is loading...
Your new post is loading...
Scooped by Krishan Maggon
Scoop.it!

Best Selling Blockbuster Monoclonal Antibodies 2017

Best Selling Blockbuster Monoclonal Antibodies 2017 | Top Selling Monoclonal Antibodies 2014 | Scoop.it

 

Abstract

 

A review of the best selling monoclonal antibodies in 2017 and previous years is provided. Humira with sales of over $19 billion ($9.3 bn in 2012, $14.5 bn in 2015 and $16 bn in 2016) remains the best selling monoclonal antibody, biologic as well the prescription drug brand in 2017. Humira has remained the top selling global brand since 2012. The ranks of the next 4 top selling mabs changed rankings from the 2012-2016 Table due to competition from biosimilars.  Rituxan (9.2 Bn) , Herceptin (7.4 Bn), Remicade (7.1 Bn) and Avastin (7.1 Bn) and were the second, third, fourth and fifth top selling mabs in 2017. The actual sales for 2017 as reported by the companies are provided. 



The global pharma biotech market for prescription medicinal brands was over $1 trillion dollar in 2017. Biologics accounted for $220 billion and  mabs for $95 billion

 

The total sales of the top selling blockbuster mabs listed in the Table were $95 billion in 2017.  Besides the top 5 mabs with sales over $7 billion, there were two monoclonal antibody with sales of over $4 billions, four with sales over $3 billion, five with sales over $ 2 billion and 3 with sales of over $ 1 billion in 2015. There were 19 blockbuster mabs in 2019. At least 5 new recently launched mabs are likely to cross sales of $ 1 billion in 2018.

 

Currently 73 monoclonal antibodies are marketed in the US and Europe (Dec. 2017).  FDA approved 6 new monoclonal antibodies in 2014, 9 in 2015, 9 in 2016 and 9 in 2017. The FDA has already approved 4 new mabs in 2018 and EMA CHMP has recommended 2 new mabs in the 1Q2018.

 

The FDA has approved only 9 biosimilar so far while EMA/CHMP has cleared 28 biosimilar so far.

 

Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.6 billion in 2017.

 

The full report is not for public release or for request by email

 

 

 

 

Krishan Maggon 's insight:

The full report is not available for public release or for request by email

 

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

European Neoantigen Summit | Hanson Wade - European Neoantigen Summit

European Neoantigen Summit | Hanson Wade - European Neoantigen Summit | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Dedicated end-to-end Europe centric meeting focused on challenges such as identifying immunogenic neoantigens...
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

IJMS | Development of a Rapid Fluorescent Immunochromatographic Test to Detect Respiratory Syncytial Virus

IJMS | Development of a Rapid Fluorescent Immunochromatographic Test to Detect Respiratory Syncytial Virus | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Human respiratory syncytial virus (RSV) is one of the most common viruses infecting the respiratory tracts of infants. The rapid and sensitive detection of RSV is important to minimize the incidence of infection.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Efficacy and safety of burosumab in children aged 1–4 years with X-linked hypophosphataemia: a multicentre, open-label, phase 2 trial

Efficacy and safety of burosumab in children aged 1–4 years with X-linked hypophosphataemia: a multicentre, open-label, phase 2 trial | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Burosumab had a favourable safety profile, increased serum phosphorus, and improved rickets and prevented early declines in growth in children aged 1–4 years with X-linked hypophosphataemia. These findings could substantially alter the treatment of young children with X-linked hypophosphataemia.
Funding
Ultragenyx Pharmaceutical and Kyowa Kirin International.

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Transcriptional Heterogeneity of Beta Cells in the Intact Pancreas

Transcriptional Heterogeneity of Beta Cells in the Intact Pancreas | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Using an optimized protocol for single-molecule transcript imaging of the intact pancreas,
Farack, Golan, et al. reveal that a small subset of beta cells harbors elevated levels
of ribosomes and insulin mRNA, suggesting a sub-specialization in basal insulin secretion.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Generation of Bispecific Antibody - Creative Biolabs

Generation of Bispecific Antibody - Creative Biolabs | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Creative Biolabs designs and generates high quality bispecific antibody products.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Antibodies | Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients

Antibodies | Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer.
more...
No comment yet.
Rescooped by Krishan Maggon from Autoimmune diseases (Lupus, RA), Vaccines and Stem Cell Therapies Highlights
Scoop.it!

Gene Expression Signature for Prediction of Golimumab Response in a Phase 2a Open-Label Trial of Patients With Ulcerative Colitis

Gene Expression Signature for Prediction of Golimumab Response in a Phase 2a Open-Label Trial of Patients With Ulcerative Colitis | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Golimumab, a tumor necrosis factor antagonist, is an effective treatment for patients
with moderate-to-severe ulcerative colitis (UC); however, more than 50% of initial
responders lose their response to the drug within the first year of therapy.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Inovio's DNA-Encoded Monoclonal Antibody (dMAb™) Platform Leaps Forward with First-in-Human Trial

Inovio's DNA-Encoded Monoclonal Antibody (dMAb™) Platform Leaps Forward with First-in-Human Trial | Top Selling Monoclonal Antibodies 2014 | Scoop.it
PLYMOUTH MEETING, Pa., Jan. 7, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) in collaboration with The Wistar Institute and the University of ...
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Performance of the Food and Drug Administration/EMA-approved programmed cell death ligand-1 assays in urothelial carcinoma with emphasis on therapy stratification for first-line use of atezolizumab...

Performance of the Food and Drug Administration/EMA-approved programmed cell death ligand-1 assays in urothelial carcinoma with emphasis on therapy stratification for first-line use of atezolizumab... | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Recently, the Food and Drug Administration (FDA)/European Medicines Agency (EMA) restricted
first-line use of atezolizumab and pembrolizumab in patients with metastasised urothelial
carcinoma by defining distinct programmed cell death ligand-1 cut-offs.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Assessment of exposure after injection of 99mTc-labeled intact monoclonal antibodies and their fragments into humans

Assessment of exposure after injection of 99mTc-labeled intact monoclonal antibodies and their fragments into humans | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Human pharmacokinetics and internal radiation dosimetry of normal organs after injection with the 99mTc-labeled monoclonal antibody (intact and fragments) are simulated by the WinAct program an
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Rituximab Combination Has Positive Activity in Non-Hodgkin Lymphoma

Rituximab Combination Has Positive Activity in Non-Hodgkin Lymphoma | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Hu5F9, an immune checkpoint inhibitor blocking CD47, has showed promise in working together with rituximab to eliminate non-Hodgkin lymphoma cells. A recent study looked to evaluate the drug in combination with rituximab in a clinical setting.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Evidence, Manipulation, and Termination of pH ‘Nano-Buffering‘ for Quantitative Homogenous Scavenging of Monoclonal Antibodies - ACS Nano (ACS Publications)

Evidence, Manipulation, and Termination of pH ‘Nano-Buffering‘ for Quantitative Homogenous Scavenging of Monoclonal Antibodies - ACS Nano (ACS Publications) | Top Selling Monoclonal Antibodies 2014 | Scoop.it
This study demonstrates that pH-responsive polymers have a very high buffering capacity in their immediate vicinity, a phenomenon termed ‘nano-buffering’. This can be exploited to dissociate local nanoscale pH from bulk solution pH. Herein, a series of pH-responsive polymers were conjugated to Protein-A to rationally manipulate the latter’s binding affinity towards antibodies via nano-buffering (i.e., this interaction is pH-dependent), independently of bulk solution pH. Moreover, the nano-buffering effect could be terminated using low concentrations of strong ion-pairing salts, to achieve quantitative release of the antibodies from the bio-conjugate. These complementary discoveries are showcased in the context of the development of a homogenous affinity precipitation agent (i.e., a scavenger) for the purification of polyclonal immunoglobulin G and two monoclonal antibodies from cell culture supernatant. Indeed, while bulk solution pH was used to induce precipitation of the scavenger, maintaining local nanoscale pH via nano-buffering maximized binding interaction with the antibodies. A 2:1 binding stoichiometry was observed, which was similar to that observed for native protein. The scavenger could be recycled multiple times, and the purification protocol circumvented lengthy/tedious physical purification processes typically associated with mAb manufacturing. Overall, this study provides perspectives on the local nanoscale pH near pH-responsive polymers, and establishes lines of thought for predictably manipulating or even terminating nano-buffering, to control the activity of proteins.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Systematically benchmarking peptide-MHC binding predictors: From synthetic to naturally processed epitopes

Systematically benchmarking peptide-MHC binding predictors: From synthetic to naturally processed epitopes | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Author summary Computationally predicting antigen peptide sequences that elicit T-cell immune response has broad and significant impact on vaccine design. The most widely accepted approach is to rely on machine learning classifier, trained on large-scale major-histocompatibility complex...
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Unique Patient Neo-Peptides To Fight Cancer – John Catanzaro –

Immunocentric innovations should be considered as a primary treatment delivery method while a patient’s disease is expressed. However, it is essential that typing and unique matching be achieved. Chemotherapeutic agents are known for cytotoxic and multi-organ system effects. We are discovering target specific agents and pulsed delivery is a less toxic regimen. Coordinated regimens of this type can be co-administered with greater efficacy. However, give the immune defenses a chance and they will work. From concept to bottling and delivery of the end product, including all the matching and analysis, was an average of 30 days.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Structural basis of a potent human monoclonal antibody against Zika virus targeting a quaternary epitope

Structural basis of a potent human monoclonal antibody against Zika virus targeting a quaternary epitope | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Abstract
Zika virus (ZIKV) is a major human pathogen and member of the Flavivirus genus in the Flaviviridae family. In contrast to most other insect-transmitted flaviviruses, ZIKV also can be transmitted sexually and from mother to fetus in humans. During recent outbreaks, ZIKV infections have been linked to microcephaly, congenital disease, and Guillain-Barré syndrome. Neutralizing antibodies have potential as therapeutic agents. We report here a 4-Å-resolution cryo-electron microscopy structure of the ZIKV virion in complex with Fab fragments of the potently neutralizing human monoclonal antibody ZIKV-195. The footprint of the ZIKV-195 Fab fragment expands across two adjacent envelope (E) protein protomers. ZIKV neutralization by this antibody is presumably accomplished by cross-linking the E proteins, which likely prevents formation of E protein trimers required for fusion of the viral and cellular membranes. A single dose of ZIKV-195 administered 5 days after virus inoculation showed marked protection against lethality in a stringent mouse model of infection.

Zika virusmonoclonal antibodymembrane-fusion inhibitionneutralization mechanismcryo-EM structure
more...
No comment yet.
Rescooped by Krishan Maggon from Hepatitis C New Drugs Review
Scoop.it!

Simtuzumab for Primary Sclerosing Cholangitis: Phase 2 Study Results With Insights on the Natural History of the Disease - Muir - - Hepatology - Wiley Online Library

Simtuzumab for Primary Sclerosing Cholangitis: Phase 2 Study Results With Insights on the Natural History of the Disease - Muir - - Hepatology - Wiley Online Library | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Lysyl oxidase like‐2 (LOXL2) plays a central role in fibrogenesis and is elevated in the serum and liver of patients with primary sclerosing cholangitis (PSC). We evaluated the safety and efficacy of simtuzumab, a monoclonal antibody directed against LOXL2, in patients with PSC. Patients with compensated liver disease caused by PSC were randomized 1:1:1 to receive weekly subcutaneous injections of simtuzumab 75 mg, simtuzumab 125 mg, or placebo for 96 weeks. The primary efficacy endpoint was mean change in hepatic collagen content assessed by morphometry between baseline and week 96. Additional endpoints included change in Ishak fibrosis stage and the frequency of PSC‐related clinical events. Overall, 234 patients were randomized and started treatment. At week 96, the mean change from baseline in hepatic collagen content was –0.5% for patients receiving simtuzumab 75 mg (P = 0.73 versus placebo), +0.5% for patients receiving simtuzumab 125 mg (P = 0.33 versus placebo), and 0.0 for patients receiving placebo. Compared with placebo, neither dose of simtuzumab led to significant reductions in Ishak fibrosis stage, progression to cirrhosis, or frequency of clinical events. Overall, 80 (34%) patients had fibrosis progression and 47 (20%) experienced PSC‐related clinical events. In a multivariate model of baseline factors, PSC‐related clinical events were more frequent in patients with advanced fibrosis (hazard ratio [HR], 2.03; 95% confidence interval [CI], 1.02‐4.06; P = 0.045), higher alkaline phosphatase (HR per 10 U/L, 1.01; 95% CI, 1.00‐1.02; P = 0.015), and higher enhanced liver fibrosis score (HR per unit, 1.26; 95% CI, 0.98‐1.61; P = 0.073). Overall, rates of adverse events and laboratory abnormalities were similar between groups. Conclusion: Treatment with the LOXL2 inhibitor simtuzumab for 96 weeks did not provide clinical benefit in patients with PSC.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Monoclonal antibodies and production of monoclonal antibodies

Monoclonal antibodies and production of monoclonal antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Antibodies that arise from a single clone of cells (e.g., myeloma) are homogenous and are called monoclonal antibodies.Method of production of monoclonal.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Autoimmune antibodies predict clinical benefit, adverse events in NSCLC

Autoimmune antibodies predict clinical benefit, adverse events in NSCLC | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Autoimmune antibodies may predict clinical benefit and immune-related adverse events in NSCLC patients receiving programmed cell death protein 1...
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

De novo design of potent and selective mimics of IL-2 and IL-15

De novo design of potent and selective mimics of IL-2 and IL-15 | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Abstract
We describe a de novo computational approach for designing proteins that recapitulate the binding sites of natural cytokines, but are otherwise unrelated in topology or amino acid sequence. We use this strategy to design mimics of the central immune cytokine interleukin-2 (IL-2) that bind to the IL-2 receptor βγc heterodimer (IL-2Rβγc) but have no binding site for IL-2Rα (also called CD25) or IL-15Rα (also known as CD215). The designs are hyper-stable, bind human and mouse IL-2Rβγc with higher affinity than the natural cytokines, and elicit downstream cell signalling independently of IL-2Rα and IL-15Rα. Crystal structures of the optimized design neoleukin-2/15 (Neo-2/15), both alone and in complex with IL-2Rβγc, are very similar to the designed model. Neo-2/15 has superior therapeutic activity to IL-2 in mouse models of melanoma and colon cancer, with reduced toxicity and undetectable immunogenicity. Our strategy for building hyper-stable de novo mimetics could be applied generally to signalling proteins, enabling the creation of superior therapeutic candidates.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Novartis crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease

Novartis crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Basel, January 8, 2019 Novartis announced today that the US Food and Drug Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic complications2. VOCs happen when multiple blood cells stick to each other and to blood vessels, causing blockages1,3. Treatments that make blood cells and blood vessels less sticky may help reduce the number of days patients experience VOCs.

 

  • Crizanlizumab is a monthly infusion under development to prevent pain crises (also called vaso-occlusive crises, or VOCs) in patients with sickle cell disease
     
  • Sickle cell VOCs, which are triggered by multi-cell adhesion or clusters of cells that block or reduce blood flow, are associated with increased morbidity and mortality1

     

  • FDA filing of crizanlizumab anticipated in first half of 2019

 

The FDA granted Breakthrough Therapy designation for crizanlizumab based on positive results of the Phase II SUSTAIN trial, which compared the P-selectin inhibitor crizanlizumab with placebo in patients with sickle cell disease. SUSTAIN showed that crizanlizumab reduced the median annual rate of VOCs leading to health care visits by 45.3% compared to placebo (1.63 vs 2.98, P=0.010) in patients with or without hydroxyurea therapy. The study also demonstrated that crizanlizumab significantly increased the percentage of patients who did not experience any VOCs vs placebo (35.8% vs 16.9%, P=0.010) during treatment4.

Patients taking crizanlizumab (5 mg/kg) experienced a similar incidence of treatment-emergent adverse events (AEs) (86.4% vs 88.7%) and serious AEs (25.8% vs 27.4%) compared to placebo, and a low incidence of discontinuations (3%) due to adverse events. Adverse events that occurred in 10% or more of the patients in either active-treatment group (2.5 mg/kg; 5 mg/kg) and at a frequency that was at least twice as high as that in the placebo group included arthralgia, diarrhea, pruritus, vomiting, and chest pain. There were no apparent increases in infections with crizanlizumab treatment4.

Krishan Maggon 's insight:

About crizanlizumab (SEG101) 
Crizanlizumab (SEG101) is a humanized anti-P-selectin monoclonal antibody being investigated for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD). Crizanlizumab binds to a molecule called P-selectin on the surface of platelets and endothelium in the blood vessels and has been shown to inhibit interactions between endothelial cells, platelets, red blood cells, sickled red blood cells, and leukocytes, causing a blockade and thereby preventing these cells from being able to bind to P-selectin. P-selectin is one of the major drivers of the vaso-occlusive process. Our goal is to deepen understanding of the true impact of VOCs on patients' bodies and lives and to explore how crizanlizumab can help to achieve more pain-crisis-free days for patients with SCD4.

more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

B-select Monoclonal Antibodies | Aduro BioTech

B-select Monoclonal Antibodies | Aduro BioTech | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Aduro has built a broad, active development pipeline of novel immunotherapies for a variety of cancer types.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Separations | Hydrophilic Monomethyl Auristatin E Derivatives as Novel Candidates for the Design of Antibody-Drug Conjugates

Separations | Hydrophilic Monomethyl Auristatin E Derivatives as Novel Candidates for the Design of Antibody-Drug Conjugates | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Antibody-drug conjugates (ADCs) are promising state-of-the-art biopharmaceutical drugs for selective drug-delivery applications and the treatment of diseases such as cancer. The idea behind the ADC technology is remarkable as it combines the highly selective targeting capacity of monoclonal...
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

GABA A receptor signalling mechanisms revealed by structural pharmacology

GABA A receptor signalling mechanisms revealed by structural pharmacology | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Type-A γ-aminobutyric (GABAA) receptors are ligand-gated chloride channels with a very rich pharmacology. Some of their modulators, including benzodiazepines and general anaesthetics, are among the most successful drugs in clinical use and are common substances of abuse. Without reliable structural data, the mechanistic basis for the pharmacological modulation of GABAA receptors remains largely unknown. Here we report several high-resolution cryo-electron microscopy structures in which the full-length human α1β3γ2L GABAA receptor in lipid nanodiscs is bound to the channel-blocker picrotoxin, the competitive antagonist bicuculline, the agonist GABA (γ-aminobutyric acid), and the classical benzodiazepines alprazolam and diazepam. We describe the binding modes and mechanistic effects of these ligands, the closed and desensitized states of the GABAA receptor gating cycle, and the basis for allosteric coupling between the extracellular, agonist-binding region and the transmembrane, pore-forming region. This work provides a structural framework in which to integrate previous physiology and pharmacology research and a rational basis for the development of GABAA receptor modulators.
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Anti-CGRP Monoclonal Antibodies: the Next Era of Migraine Prevention?

Anti-CGRP Monoclonal Antibodies: the Next Era of Migraine Prevention? | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Migraine is a very disabling disorder with severe impact on patients’ lives and substantive costs to society in terms of healthcare costs and lost productivity. Prevention is a key componen
more...
No comment yet.
Scooped by Krishan Maggon
Scoop.it!

Alexion Receives Early FDA Approval for ULTOMIRIS™ (Ravulizumab-cwvz) in Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) 

Alexion Receives Early FDA Approval for ULTOMIRIS™ (Ravulizumab-cwvz) in Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)  | Top Selling Monoclonal Antibodies 2014 | Scoop.it
BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved ULTOMIRIS™ (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating ultra-rare blood disorder characterized by complement-mediated destruction of the red blood cells (hemolysis).
more...
No comment yet.