Tarrytown-based Regeneron has received an emergency use authorization from the U.S. Food and Drug Administration allowing use of its REGEN-COV2 antibody cocktail for the treatment of Covid-19 in high-risk patients with mild to moderate cases of the virus.
The authorization came in a letter dated Saturday, Nov. 21, to Regeneron that was signed by Denise M. Hinton, chief scientist for the FDA.
In a statement, agency Administrator Stephen M. Hahn said, “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.”
Regeneron said that initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under a government allocation program.
It said that this is the “first treatment of any kind to have prospectively confirmed and statistically significant antiviral activity against SARS-CoV-2” (Covid-19). When President Trump was hospitalized at Walter Reed National Military Medical Center for treatment of Covid-19, he was given a dose of the Regeneron antibody cocktail along with other medications. It was approved for use on Trump under an FDA process permitting compassionate use of experimental medications in certain circumstances.
“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,” said Leonard S. Schleifer, president and CEO of Regeneron.
“The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with (pharmaceutical company) Roche.”
The drug cocktail consists of the monoclonal antibodies casirivimab and imdevimab administered together. The company said that clinical evidence from its outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.
The authorization does not allow use of the cocktail on patients who already have been hospitalized as a result of the virus or require oxygen therapy either because of Covid-19 or because of an underlying condition.
George D. Yancopoulos, president and chief scientific officer for Regeneron, said, “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus. Data from approximately 800 nonhospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors.”
Schleifer and Yancopoulos recently were named as the Business Journal’s executives of the year because of their achievements in founding and building Regneron.
Regeneron said it expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January and approximately 300,000 patients in total by the end of January 2021.
