Regeneron Gets Limited Usage by US FDA

The FDA changed the emergency use authorizations for Regeneron and Eli Lilly’s COVID-19 antibody therapies on Monday, limiting their use because the medications are unlikely to operate against the Omicron coronavirus type. The medicines are currently not approved for use in any U.S. states or territories, but they may be approved in certain areas if they work against prospective new variations, according to the Food and Drug Administration.

Other treatments that could be successful against Omicron, according to the FDA, include a competitor antibody medicine from GlaxoSmithKline and Vir Biotechnology, as well as recently approved antiviral tablets from Pfizer and Merck & Co. The US authorities halted the delivery of Regeneron and Lilly’s therapies last month, saying the halt would last until fresh data on their efficacy against Omicron became available.

As of Jan. 15, the extremely contagious new strain was believed to be responsible for more than 99 percent of cases in the United States. To assist satisfy surging demand in the United States, GSK and Vir Biotech are increasing production of their medicine, sotrovimab. The FDA has also extended its approval for Gilead Sciences’ products. The FDA was expected to revise authorizations for Regeneron and Lilly’s therapies, according to the Washington Post earlier in the day.

Regeneron stated that it is collaborating with the FDA to provide more monoclonal antibody medicines to patients. Lilly had no immediate response, but linked to a December announcement in which the company stated that their antibody candidate, bebtelovimab, has neutralising activity against all known variations of concern, including Omicron.