Monoclonal Antibody Cocktail Authorized for Put up-COVID Publicity

FDA expanded the emergency employ authorization (EUA) for the monoclonal antibody cocktail casirivimab and imdevimab, to encompass put up-publicity prophylaxis (PEP) among determined of us exposed to COVID-19, producer Regeneron announced on Friday.

Casirivimab-imdevimab (REGEN-COV) is the first monoclonal antibody therapy that would even be extinct either as a therapy for COVID-19 or after publicity nonetheless earlier than a lunge COVID-19 take a look at, Regeneron acknowledged.

The unusual indication covers participants ages 12 and older who had been exposed to somebody with the virus or who had been exposed to the virus in an institutional atmosphere.

In a section III trial jointly subsidized by NIAID, the cocktail reduced the menace of symptomatic infections by 81% when extinct as PEP among family contacts of individuals with SARS-CoV-2.

Particularly, the therapy is for these at excessive menace of progressing to extreme COVID-19 who either weren’t completely vaccinated or “not expected to mount an sufficient response to vaccination,” to boot to for these with a excessive menace of publicity, corresponding to in nursing house or penal complex settings.

Now not simplest that, nonetheless the cocktail could maybe perhaps perhaps be administered month-to-month for folk who “require repeat dosing for ongoing publicity,” Regeneron acknowledged. The EUA for the therapy as PEP diagram it could maybe even be administered by subcutaneous injection or intravenous infusion.

Regeneron expanded on the outcomes of the section III trial to reduction the expanded indication, which consisted of 1,500 seronegative members, 753 randomized to REGEN-COV and 752 randomized to placebo. As well to lowering the menace of symptomatic an infection by 81%, a put up-hoc analysis chanced on a menace cut rate of 76% among a subgroup of members at excessive menace of extreme COVID in the REGEN-COV crew.

In a broader crew of two,378 asymptomatic members, no topic serology, a put up-hoc analysis chanced on a menace cut rate of 62% in the REGEN-COV crew.

Hostile events incorporated gentle to moderate injection plot reactions in as much as 4% of individuals receiving the therapy. Gentle hypersensitivity reactions happened in lower than 1% of the REGEN-COV crew.

Regeneron touted the cocktail’s potency against a form of variants, including the Delta variant, and added that the therapy just is not a change for vaccination, and just is not authorized for COVID-19 pre-publicity prophylaxis.

Beforehand, the cocktail used to be authorized in November 2020 for non-hospitalized patients ages 12 and older who examined lunge for SARS-CoV-2 and had been at elevated menace of progressing to extreme COVID-19, including these ages 65 and older with persistent medical prerequisites.