Morning Briefing
Summaries of health policy coverage from major news organizations
First Antibody Treatment Gets FDA Emergency Approval
In more good news for the fight against COVID-19, the U.S. Food and Drug Administration late Monday authorized use of a drug that appears to protect infected people at high risk from getting very sick. The FDA issued an emergency use authorization to drug-maker Lilly for bamlanivimab, a monoclonal antibody that mimics the immune system’s response to infection with the virus that causes COVID-19. (Weise and Weintraub, (11/9)
Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. A study of it in hospitalized patients was stopped when independent monitors saw the drug did not seem to be helping in that situation. The government previously reached an agreement to buy and supply much of the early production of Lilly’s drug. Only one drug -- Gilead Sciences’ remdesivir -- has full FDA approval for treating COVID-19. Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalized patients. (Perrone, 11/10)
The drug, bamlanivimab, must be delivered by intravenous infusion early in the illness. It was authorized for use in patients with mild or moderate cases of the coronavirus who are at high risk of severe disease or hospitalization. Risk factors include being older than 65, diabetes, obesity with different body mass index cutoffs depending on age, a suppressed immune system, and cardiovascular disease or high blood pressure in people over age 55. (Johnson, 11/9)
The authorization, announced on Monday, applies only to people newly infected with the virus, and the agency said it should not be used in hospitalized patients. The treatment is approved for people 12 and older who have tested positive and are at risk for developing a severe form of Covid-19 or being hospitalized for the condition. That includes people who are over 65 and obese, the agency said — a key group that early studies have shown can benefit the most from the treatment. (11/10)
