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Saturday, February 4, 2023

U.S. authorizes Regeneron’s COVID-19 antibody therapy for injection

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The U.S. health regulator authorized a lower dose of Regeneron Pharmaceutical’s COVID-19 antibody cocktail that can be given by injection, a move that could ease logistical challenges stemming from administering a higher dose intravenously.

The therapy, REGEN-COV, and a similar treatment developed by rival Eli Lilly (LLY.N) were being given through one-time infusion and required patients to be isolated.

Regeneron had been working on a lower dose of its cocktail that can be given subcutaneously to address the challenges that have weighed on demand for antibody drugs.

The U.S. Food and Drug Administration had in November authorized a 2,400 mg dose of REGEN-COV, administered as a single dose directly injected to a vein for non-hospitalized COVID-19 patients.

The agency has now lowered it to 1,200 mg and allowed the administration of casirivimab and imdevimab by injecting under the skin when intravenous infusion is not possible and would lead to treatment delay, Regeneron said on Friday.

The therapy belongs to a class of drugs called monoclonal antibodies, which mimic natural antibodies the body produces to fight off the infection.

Eli Lilly’s antibody combination received U.S. emergency use authorization in February, while an antibody drug by Vir Biotechnology Inc (VIR.O) and GlaxoSmithKline PLC (GSK.L), which is also administered through intravenous infusion, was granted authorization late last month. read more

Regeneron said it expects to submit an application for full approval of REGEN-COV in non-hospitalized patients later this summer.

The drugmaker expects to deliver at least 1 million doses of the therapy to the U.S. government in the second quarter and said the government may accept additional doses of up to 1.25 million doses through September.

Regeneron is also developing the cocktail as a preventive medicine.

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