The FDA approved an anti-inflammatory treatment for treating COVID-19 despite a lack of statistical evidence.
InflaRx, a German pharmaceutical firm, said in a press release on Monday that the FDA has approved their drug vilobelimab for treating patients with severe cases of COVID.
The medication, also known by the name Gohibic, must be administered within 48 hours of the initiation of life-sustaining respiratory support measures, such as invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). These measures are usually taken for patients with life-threatening cases of acute respiratory failure.
Gohibic, similar to Eli Lilly’s Olumiant and Roche’s Actemra, does not directly neutralize the SARS-CoV-2 coronavirus; instead, it acts by curbing harmful immune overreactions during COVID. Nevertheless, Gohibic is the only FDA-approved medicine that may selectively inhibit immune complement factor C5a, which the FDA has linked to COVID-related inflammation and virus deterioration.
InflaRx CEO Niels Riedemann said in a news statement that the EUA gives patients renewed hope if they suffer viral sepsis despite vaccination and other therapeutic choices. Gohibic is in stock and production is being ramped up at a contractor by InflaRx.
Gohibic was approved after a surprising turn in phase 3. Data published in The Lancet Respiratory Medicine from the randomized PANAMO study shows that Gohibic decreased the probability of mortality in the sickest patients by 27% when compared to placebo over a period of 28 days. The primary endpoint of the experiment was not reached with those results. Nonetheless, the drug’s efficacy was confirmed by a second specified analysis and two post hoc tests.
Prof. Renfeng Guo, the founder of InflaRx, stated: “This EUA is a great recognition of our COVID-19-related research, which was based on over two decades of groundbreaking work on the tissue and organ-damaging effect of the complement factor C5a as part of the body’s immune response.”
Notwithstanding the mixed findings, InflaRx spoke with the FDA and submitted an EUA application last September.
The development of vaccinations and antiviral medications – like Pfizer’s Paxlovid – to stop the progression of the illness in moderately ill people has made COVID much more manageable. Yet, Riedemann pointed out, the U.S. continues to report around 2,000 fatalities each week attributable to COVID.
According to InflaRx, talks with the FDA on a possible application for complete approval of Gohibic in COVID are ongoing. Prior to the EUA for Gohibic, the FDA had already approved two other drugs for the treatment of COVID in hospitalized individuals, including those who need invasive mechanical ventilation or ECMO: the JAK inhibitor Olumiant and the IL-6 inhibitor Actemra.
Both Olumiant and Actemra sales have lately settled down after experiencing an early uptick due to the increased popularity of COVID treatment.
AstraZeneca’s best-selling medicines Soliris and Ultomiris work by inhibiting C5a and C5b, respectively. Gohibic was developed with the intention of preserving C5b, which is an essential component of the innate immune system’s defensive mechanisms.
InflaRx is conducting research on Gohibic for several disorders, including a future phase 3 trial focusing on the uncommon skin ailment pyoderma gangrenosum. A phase 2 research for cutaneous squamous cell carcinoma is also being conducted by the company.