FDA Grants Emergency Use to Regeneron’s COVID-19 Antibody Cocktail

FDA recently issued an emergency use authorization to Regeneron for its COVID-19 antibody cocktail, formerly known as REGN-COV2. 

The cocktail is made up of casirivimab and imdevimab.

The authorization allows healthcare providers to administer the drugs together by intravenous (IV) infusion to infected adults and pediatric patients 12 years of age or older, as long as they weigh at least 88 pounds.

Providers may also administer the drug combination to individuals who are at high risk of progressing to severe COVID-19 and to patients 65 years of age or older who have certain underlying conditions. 

But the cocktail is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy, as the antibodies may generate worse clinical outcomes. 

“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement. 

“As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments,” he continued.

The data supporting the emergency use authorization are based on a Phase 2/3 randomized, double-blind, placebo-controlled clinical trial of 799 non-hospitalized adults with mild to moderate COVID-19 symptoms. 

In the trial, casirivimab and imdevimab met the primary and key secondary endpoints and significantly reduced viral load and patient medical visits, including hospitalizations, emergency room, urgent care visits, and physician office or telemedicine visits. 

Most notably, the antibody cocktail reduced medical visits related to COVID-19 by 57 percent through Day 29 and reduced medical visits by 72 percent in patients with one or more risk factors. 

Specifically, hospitalizations and emergency room visits occurred in three percent of casirivimab and imdevimab-treated patients on average compared to nine percent in placebo-treated patients.

But overall, the safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated, FDA stated. 

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”

At the beginning of the pandemic, Regeneron and the Biomedical Advanced Research and Development Authority (BARDA) rapidly scaled up the production of casirivimab and imdevimab. 

Then at the end of August, Regeneron partnered with Roche to develop, manufacture, and distribute the COVID-19 antibody cocktail. 

The companies stated that they will increase the supply of REGN-COV2 to at least three and a half times the current capacity, with potential for even further expansion.

Specifically, Regeneron anticipates to dose nearly 80,000 patients by the end of November, 200,000 patients by the first week of January, and 300,000 patients in total by the end of January 2021.

“This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection,” Leonard S. Schleifer, MD, PhD, president and chief executive officer of Regeneron, said in a press release.

“Demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available global supply as we continue our collaboration with Roche,” Schleifer concluded.