InflaRx's Vilobelimab Receives Positive CHMP Opinion for SARS-CoV-2-Induced ARDS
核心洞察
The CHMP has recommended marketing authorization for InflaRx (搜索)'s vilobelimab (GOHIBIC®) for treating SARS-CoV-2-induced ARDS (搜索) in mechanically ventilated adults.
The positive opinion is based on Phase 3 PANAMO trial results, which showed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo.
Vilobelimab, a first-in-class anti-C5a (搜索) antibody, has already received Emergency Use Authorization from the FDA for treating COVID-19 (搜索) in hospitalized adults.
InflaRx (搜索) N.V. (Nasdaq: IFRX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for vilobelimab (GOHIBIC®), recommending its marketing authorization under exceptional circumstances. This authorization is intended for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (搜索) (ARDS (搜索)) who are receiving systemic corticosteroids as part of standard care and undergoing invasive mechanical ventilation (IMV), with or without extracorporeal membrane oxygenation (ECMO).
The company anticipates the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days.
Clinical Trial Data and Outcomes
The positive CHMP opinion is backed by results from the Phase 3 PANAMO trial, a multicenter, 1:1 randomized, double-blind, placebo-controlled study involving invasively mechanically ventilated COVID-19 (搜索) patients in intensive care units. The trial demonstrated that vilobelimab treatment improved survival, resulting in a 23.9% relative reduction in 28-day all-cause mortality compared to placebo in the global data set. The study has been published in The Lancet Respiratory Medicine.
Vilobelimab: Mechanism of Action
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a (搜索) antibody. It selectively blocks the biological activity of C5a while leaving the formation of the membrane attack complex (C5b-9) intact, preserving a crucial defense mechanism of the innate immune system. Pre-clinical studies have indicated that vilobelimab can control inflammatory response-driven tissue and organ damage by specifically blocking C5a.
Commercialization and Future Plans
InflaRx (搜索) plans to commercialize vilobelimab in Europe under the brand name GOHIBIC®. The company is evaluating commercial distribution options with potential partners in the EU. As part of the marketing authorization terms, InflaRx will provide annual updates to the EMA on the clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA), in which vilobelimab is included as one of three potential therapies for treating ARDS (搜索).
Current Status and Safety Information
Vilobelimab has been granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for treating COVID-19 (搜索) in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO.
Serious infections and hypersensitivity reactions have been observed with vilobelimab. Common adverse reactions (incidence ≥3%) include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, and deep vein thrombosis.