Susan Walsh / AP
One of the experimental drugs that President Trump received while fighting the coronavirus has been approved for emergency use by the Food and Drug Administration. The drug, manufactured by biotechnology company Regeneron, is the second antibody treatment to receive FDA approval.
The treatment combines two antibodies – kazirivimab and imdevimab – and administers them together IV. In a clinical trial of about 800 people, the cocktail was shown to significantly reduce virus levels within days of treatment.
In its authorization on Saturday, the FDA clarified that the drug is only intended for the treatment of mild to moderate COVID-19 in people 12 years of age and older who are at high risk of developing more severe symptoms. Not for patients who are hospitalized for COVID-19 or who need oxygen therapy for the virus.
“The urgent resolution of these monoclonal antibodies, applied together, offers healthcare providers another tool to combat the pandemic,” said Dr. Patricia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”
Both Regeneron and another approved treatment by Eli Lilly are synthetic versions of human antibodies that mimic the ability of the immune system to fight harmful pathogens. They bind to the coronavirus and prevent it from invading the cells.
The White House celebrated the “promising results” and noted that the administration had spent nearly half a billion dollars to support large-scale production of Regeneron antibody treatment for delivery to US hospitals.
“Because of advances in quality care, information for medical personnel to better treat patients, and life-saving vaccines that are rapidly advancing for approval faster than ever, the United States has never been better prepared to resist the coronavirus and save millions of lives as we already are, “White House spokesman Michael Bars said in a statement.
Regeneron’s drug, called REGEN-COV2, “is designed to mimic what a well-functioning immune system does, using very powerful antibodies to neutralize the virus,” Regeneron’s chief scientific officer, George Jankopoulos, said in a statement. “We are encouraged that no cocktail-resistant variants have been identified in clinical trial analyzes to date.”
Both Eli Lilly and Regeneron applied for FDA approval in October. Eli Lilly’s product received the green light first, and their first batch was distributed to hospitals across the country. The Regeneron product will now be available to increase supply, and the company estimates that 300,000 doses will be given to patients free of charge, although together they will still not be enough to serve all people who could qualify for them.
Neither drug has yet received full FDA approval, which requires much stricter, more time-consuming examinations. Emergency authorizations are granted during public health emergencies where treatment can be effective.
On Thursday, the FDA issued an additional emergency authorization for baricitinib, which, when used with remdezivir, has been shown to be effective in combating more severe cases of COVID-19 requiring hospitalization or ventilation.
Richard Harris of NPR contributed to this report.