By Carolyn Crist
The FDA granted an emergency use authorization for a monoclonal antibody therapy to treat mild to moderate COVID-19 in adults and children over age 12, the agency announced Monday.
The treatment, called bamlanivimab, was created by Eli Lilly and Co. and must be used in a hospital or other health care facility. It's the first antibody drug combination, or "cocktail," to receive emergency authorization.
"Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses," the FDA wrote in the statement.
The treatment targets the spike protein on the coronavirus and is meant to block the virus from attaching to and entering human cells. At this time, the Eli Lilly treatment is not authorized for patients who are hospitalized with severe COVID-19 or need oxygen. In fact, monoclonal antibodies may create worse outcomes for those who need oxygen or ventilation, the FDA said.
But the treatment may help those who face a high risk of progressing toward severe COVID-19 or hospitalization, including people over age 65 or those who have a chronic medical condition. During clinical trials, the treatment reduced hospitalizations and emergency room visits in high-risk patients and reduced some symptoms in patients with mild COVID-19.
The treatment should be given as soon as possible after a positive COVID-19 test and within 10 days of symptoms beginning, the FDA said. The therapy can be used only in a hospital or health care setting so doctors can monitor any negative reactions.
Eli Lilly secured a $375 million deal with the federal government in late October to produce 300,000 vials of the antibody treatment, according to CNN. The company applied for an emergency use authorization in October and will have 100,000 doses available for shipment this month.
"Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government's allocation program," the company wrote in a statement on Monday.
Regeneron, which also developed an antibody therapy, applied for emergency use authorization in October, but that hasn't yet been approved. Regeneron's therapy was given to President Donald Trump when he was treated for COVID-19 in October.
Scientists are still testing bamlanivimab in clinical trials to obtain full FDA approval.
"We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available," Patrizia Cavazzoni, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in the FDA statement.