Just as Regeneron’s COVID-19 antibody combination, REGEN-COV, is sidelined in the U.S. thanks to omicron, the drug has hit a hiccup on its quest for a full FDA nod.
The FDA has extended the review of REGEN-COV by three months to July 13, Regeneron said Thursday. The agency wants to take the time to review additional data on how well the therapy could prevent COVID before exposure to the SARS-CoV-2 virus, the company said.
An FDA nod in what’s known as the pre-exposure prophylaxis setting would be an expansion from REGEN-COV’s existing emergency use authorization, which currently only covers treatment of mild-to-moderate non-hospitalized patients and COVID prevention after exposure to the coronavirus. Regeneron is currently seeking full approval for all three uses.
