A statistical shortfall didn’t dissuade the FDA from authorizing an anti-inflammatory therapy for treating COVID-19.
The FDA has granted an emergency use authorization for InflaRx’s vilobelimab to treat critically ill COVID patients, the German company said in a press release Monday.
The drug also bears the moniker Gohibic, and it’s only allowed for use within 48 hours of a patient receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), which are typically utilized in the most severe patients experiencing acute respiratory failure.
Gohibic, like Eli Lilly’s Olumiant and Roche’s Actemra, works by tamping down dangerous immune overreactions during COVID, rather than directly neutralizing the SARS-CoV-2 coronavirus. But Gohibic is now the first authorized drug to specifically block immune complement factor C5a, which, according to the FDA, is thought to contribute to inflammation and worsening of COVID.
The EUA brings new hope to patients who, despite vaccines and other treatment options, are still developing viral sepsis and are progressing to critical status, InflaRx CEO Niels Riedemann said in the press release.
Gohibic got the green light after a phase 3 twist. In the randomized PANAMO trial, Gohibic reduced the risk of death in the sickest patients by 27% compared with placebo during a 28-day period, according to data published in The Lancet Respiratory Medicine. That showing missed statistical significance on the trial’s primary endpoint. But on another predefined analysis and two post hoc analyses, the drug’s improvement was statistically significant.
Despite the mixed results, InflaRx talked to the FDA and applied for EUA last September.
InflaRx has a supply of Gohibic readily available now that can treat several thousands of patients, Riedemann told investors during a call Wednesday. The company also has a manufacturing agreement in place with a contractor.
Riedemann said he couldn’t share Gohibic’s price yet, but the company expects to charge a five-digit figure and that “it will not have a one as first figure.” InflaRx also received positive feedback from payers because of the drug’s lifesaving potential, he added.
Five-figure list prices are commonplace in biologic drugs like Gohibic. Gilead Sciences’ small molecule antiviral Veklury costs about $3,200 for a treatment course. And, as Riedemann noted, Veklury has a much broader patient base, covering both nonhospitalized and hospitalized patients.
InflaRx also doesn’t have a speicifc launch date yet as it still needs to label the drugs and open distribution channels, Riedemann said. But the launch will be focused on large hospitals and specialty institutions with extensive care units, where the most severe COVID patients are being treated, he said.
Thanks to the adoption of vaccines and drugs like Pfizer’s Paxlovid to prevent worsening of disease in mild patients, COVID has largely become a manageable condition. But still, the U.S. reports roughly 2,000 COVID-related deaths per week, Riedemann noted.
InflaRx said it continues to discuss with the FDA a potential application for a full approval of Gohibic in COVID. Before Gohibic’s EUA, JAK inhibitor Olumiant and IL-6 blocker Actemra—both originally used for rheumatoid arthritis—were repurposed for COVID and earned full FDA approvals to treat hospitalized COVID patients including those who require invasive mechanical ventilation or ECMO.
After an initial surge from COVID use, sales of both Olumiant and Actemra have recently come back to Earth.
As for the C5 inhibition mechanism, AstraZeneca’s blockbuster drugs Soliris and Ultomiris target both C5a and C5b. Gohibic is designed to leave C5b intact as an important defense mechanism of the innate immune system.
InflaRx is evaluating Gohibic for other diseases, including a planned phase 3 study in pyoderma gangrenosum, a rare skin disorder. The company is also running a phase 2 study in the skin cancer cutaneous squamous cell carcinoma.
Editor's note: The story was updated April 5 to include additional comments that InflaRx CEO Niels Riedemann made during a conference call.