The U.S. Food and Drug administration granted priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
GSK said on December 7 the British drugmaker’s antibody-based Covid-19 therapy with U.S. partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies.
The U.S. Food and Drug Administration expanded the emergency use authorization of Regeneron Pharmaceuticals Inc.’s Covid-19 antibody cocktail, enabling the combo therapy’s use as a preventive treatment for the illness in certain people.
Pfizer Inc., Merck & Co. Inc., Roche Holding AG, and other companies are racing to produce the first antiviral pill that people could take at early signs of Covid-19. Their shared goal: filling a key treatment hole by helping people recently infected with the novel coronavirus to avoid becoming seriously ill and needing hospitalization.
Vir Biotechnology and Britain’s GlaxoSmithKline said on March 3 they would pause enrollment into a study testing their experimental Covid-19 antibody therapy, which is a part of a large U.S. trial.
U.S. hospitals have been slow to embrace Covid-19 antibody drugs from Eli Lilly and Co. and Regeneron Pharmaceuticals Inc. that were authorized to reduce the risk of hospitalization, U.S. officials said.
The U.S. government will start distributing Regeneron Pharmaceuticals Inc.’s newly authorized Covid-19 antibody combination on Nov. 24, beginning with more than 30,000 treatment courses, a health official said.
The U.S. Food and Drug Administration will make public reviews of all data and information regarding the emergency use authorization (EUA) granted to Covid-19 drugs and vaccines.
U.S. regulators authorized emergency use of the first experimental antibody drug for Covid-19 in patients who are not hospitalized but are at risk of serious illness because of their age or other conditions.
The U.S. government will pay as much as $1.19 billion to Eli Lilly to secure nearly 1 million doses of the company’s experimental Covid-19 antibody treatment, a drug similar to a treatment that U.S. President Donald Trump received.