InflaRx Covid-19 Drug Welcomes an FDA Win | Virus World | Scoop.it
From medcitynews.com - April 6, 2023 8:56 PM

Covid-19 antibody drug developers have had a rough time. One by one, antibody medicines that reached the market under emergency use saw their authorized indications narrowed and then revoked by the FDA due to ineffectiveness against newer strains of the virus. By the end of last year, no Covid-19 antibody drugs remained authorized for use in the U.S. InflaRx is showing that Covid-19 antibody drug research is still alive. The FDA this week authorized the biotech’s antibody, vilobelimab, as a treatment for Covid-19 in hospitalized adults. The drug is meant for severe cases. The authorization specifies treatment must start within 48 hours of the patient receiving mechanical ventilation or artificial life support. Jena, Germany-based InflaRx will market its new product under the name “Gohibic.” The antibody drugs whose authorizations were revoked all targeted some part of SARS-CoV-2 in order to prevent it from infecting cells. InflaRx’s target isn’t on the virus. The biotech’s antibody addresses a part of the immune response believed to play a role in the inflammation that leads to Covid-19 progression. The drug targets C5a, a protein of the complement system, which is a part of the immune system.

 

Authorization of InflaRx’s drug provides an alternative to Olumiant, an Eli Lilly drug. Like Gohibic, Olumiant is also authorized for treating hospitalized patients within 48 hours of starting mechanical ventilation or artificial life support. This Lilly drug works by blocking JAK proteins associated with inflammation. But Olumiant is a small molecule made into a pill—a challenging formulation for patients receiving breathing assistance. Olumiant can be dissolved in water and swallowed or administered via a gastrointestinal tube. But InflaRx’s Gohibic provides yet another dosing option, as that drug is administered as an intravenous infusion. InflaRx initially developed its antibody as a treatment for hidradenitis suppurativa, a rare inflammatory skin disorder. In 2019, the antibody drug failed a Phase 2b test in that indication. With the onset of the pandemic the following year, InflaRx began a clinical trial testing the antibody in Covid-19 patients. The Gohibic EUA request was based on data from a placebo-controlled Phase 3 study that enrolled 369 mechanically ventilated patients in intensive care units. According to study results, after 28 days, the treatment group showed a 23.9% reduction in death from all causes compared to the placebo arm. The most common adverse reactions reported in the study included pneumonia, sepsis, delirium, and pulmonary embolism. The FDA also said serious infections have been reported in Covid-19 patients who received Gohibic. Now that InflaRx has emergency authorization for Gohibic, the company said it is communicating with the FDA about the next steps for a biologics license application seeking full regulatory approval. The company is having similar discussions with regulators in Europe.

 

FDA Press Release (April 4, 2023):

https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-gohibic-vilobelimab-injection-treatment-covid-19