Regeneron’s Covid-19 Drug Is Authorized for Injection

Regeneron’s monoclonal antibody drug, called REGEN-COV, has been available to treat recently diagnosed Covid-19 since last November under an emergency-use authorization from the U.S. Food and Drug Administration. In clinical trials, the drug reduced the risk of hospitalization or death by 70% in people with mild to moderate symptoms.

Yet the drug has gone underused, according to public health officials, in part because it requires intravenous infusions that not all clinics and hospitals are equipped to administer.

Under the new authorization, the FDA permitted a simpler formulation, in which patients receive an injection shot underneath the skin in cases where IV infusions aren’t feasible or would lead to a delay in treatment, Regeneron said.

In addition, the FDA allowed for the drug to be combined in a single vial, which could reduce the time it takes for nurses to prepare the treatment.

REGEN-COV is a combination of two monoclonal antibodies that before the FDA’s latest authorization had to be stored in separate vials and mixed together by nurses before administering the drug to patients.

“Unfortunately, to date only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization,” said George D. Yancopoulos, president and chief scientific officer at Regeneron.

The FDA also cleared a lower dose of the drug that is about half the strength of the originally authorized dose, which will increase the total number of doses available for patients under Regeneron’s contract with the U.S. government.

Regeneron said it expects to deliver at least one million doses to the government this quarter, which ends June 30.

Antibody drugs are lab-made versions of the natural antibodies produced by the immune system to fight viruses. Regeneron’s Covid-19 antibodies are modeled on those isolated from survivors of the disease and genetically-engineered mice.

Regeneron, of Tarrytown, N.Y., said that lab tests show the drug remains effective against virus variants circulating in the U.S., which scientists have worried could prove resistant to antibody drugs.

A rival antibody drug made by Eli Lilly & Co. has proven ineffective against some virus variants, leading the U.S. Department of Health and Human Services to stop shipping the drug to eight states where the variants are rising in prevalence.

Regeneron said it would seek full approval for REGEN-COV later this summer. The company earlier this year asked the FDA to authorize the drug to prevent Covid-19 in people exposed to the virus who haven’t been vaccinated yet, which could provide stopgap protection as people await vaccines.

A third antibody drug, from Vir Biotechnology Inc. and GlaxoSmithKline PLC, was authorized by the FDA last month.

Write to Joseph Walker at [email protected]