EMA Recommends Gohibic for ARDS Induced by SARS-CoV-2
Following a consultation with its emergency task force, the European Medicines Agency (EMA) has backed a drug for adult patients with acute respiratory distress syndrome (ARDS) induced by the SARS‑CoV-2 virus.
As a result, the EMA’s Committee for Medicinal Products for Human Use recommended granting a marketing authorization “under exceptional circumstances” for Gohibic (vilobelimab).
Gohibic is a recombinant chimeric monoclonal IgG4 antibody that binds to and blocks activity of the human complement factor C5a receptor. In reaching its decision, the committee considered evidence that showed patients with ARDS who also receive corticosteroids had reduced mortality at days 28 and 60 after starting treatment with Gohibic when compared with standard of care.
Side Effects and Administration
The most common side effect associated with Gohibic is pneumonia, reported in 21.7% of patients. Other negative effects are herpes simplex (6.3%), bronchopulmonary aspergillosis (5.7%), and sepsis (5.1%).
The full indication for Gohibic is as a treatment for adult patients with SARS‑CoV-2‑induced ARDS who are receiving systemic corticosteroids as part of standard of care as well as invasive mechanical ventilation with or without extracorporeal membrane oxygenation.
Gohibic will be available in the form of a 200 mg concentrate for solution for infusion.
The committee specified that injection with Gohibic should be initiated and monitored by a physician experienced in the management of patients treated in an intensive care unit setting.
Exceptional Authorizations
Marketing authorizations can be recommended by the EMA in exceptional circumstances when an applicant can show that provision of comprehensive data on a medicine is not possible due to the rarity of the condition it is intended for, limited scientific knowledge, or ethical considerations in collecting data.
A final decision on a marketing authorization is now in the hands of the European Commission.
Peter Russell has been a journalist for 40 years covering international news, health, medicine, and national politics on radio, TV, and online. He is based in the UK.
