The emergency use authorization (EUA) for bebtelovimab, the only COVID-19 antibody treatment remaining on the U.S. market, was withdrawn yesterday because of lack of efficacy against the omicron variants of SARS-CoV-2 now circulating, according to news reports in the Wall Street Journal and other outlets. The Journal notes that an EUA for tocilizumab (Actemra) remains in effect for treatment of COVID-19, but the agent was not originally approved for that indication, and that tixagevimab copackaged with cilgavimab (Evusheld) has an EUA for prevention of COVID-19.
FDA yesterday approved the first-in-class fecal microbiota live biotherapeutic, Rebyota (fecal microbiota, live-jslm). The Ferring Pharmaceuticals product is approved for the prevention of the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI. The approval was handled using FDA’s fast track, breakthrough therapy, and orphan designations and was based on results of the phase 3 PUNCH CD3 trial.