The Food and Drug Administration has authorized the emergency use of a coronavirus antibody treatment for certain patients.
On Monday, the FDA approved Eli Lilly & Co’s bamlanivimab drug based on trial data that showed a lowered rate of hospitalizations after a one-time use of the treatment. The treatment has not been authorized for universal use among COVID-19 patients, but it will be given to adults 65 years or old or people over the age of 12 with existing health conditions.
“Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells,” the FDA said in a statement.
The authorization was based on a study published in the New England Journal of Medicine in October. The Phase 2 trial involved 452 patients, some of whom were given bamlanivimab, while others were given a placebo. Out of the patients who received the treatment, 1.6% had their symptoms progress to the point of hospitalization, while the group that received the placebo was hospitalized at a 6.3% rate.
“The FDA’s emergency authorization of bamlanivimab provides healthcare professionals on the front line of this pandemic with another potential tool in treating COVID-19 patients,” Dr. Patrizia Cavazzoni, the acting director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
The federal government previously agreed to a deal worth $375 million with Eli Lilly to provide the first doses of its experimental antibody treatment.
Also on Monday, Pfizer and BioNTech announced that one of its vaccine candidates had a more than 90% effectiveness in preventing COVID-19. They will seek an emergency use authorization from the FDA after they report additional safety data from the second dose of the vaccination. They expect to have that data by the third week of November.
