Invivyd’s COVID prophylactic scores FDA emergency nod for people with weakened immune systems – FiercePharma

The four years since the start of theCOVID-19 pandemic have yielded many advances against the coronavirus, includingModerna and Pfizers groundbreaking mRNA vaccines.

But for those with compromised immune systems who often don't have adequate responses to vaccination, daily life has remained difficult.

Now,Invivyds Pemgarda has scored an FDA emergency use authorization as a pre-exposure prophylaxis (PrEP)for these individuals.

Invivyd's med targets those 12 and older who have moderate-to-severe immune compromise due to certain medical conditions or immunosuppressive treatments and who are unlikely to achieve an adequateresponse to COVID-19 vaccination, the company said in a press release.

Previously, AstraZeneca'sEvusheldgained an FDA endorsement for PrEP use inimmunocompromised people, but it was later withdrawn.

Pemgarda, which is administered through intravenous infusion, is set to hit the market imminently, with initial supply already packaged and ready to go, Inivyds CEO Dave Hering said in the company's release.

Its been long known that the virus disproportionally impacts those who are immunocompromised, causing a higher rateof hospitalization and death than among the wider population.

Plus, after the arrival of a new dominant COVID strain called JN.1, which the CDC says may be intensifying the virus' spread, Pemgarda'sdebutis timely.

The FDA endorsed the therapy after Invivydran an immunobridgingstudy to show that patients who received Pemgarda had serum-neutralizing antibody titers against JN.1 that were consistent with the levels linked with efficacy in previous studies of adintrevimab.

The biotech previously stopped research on adintrevimabbecause the antibody couldn't keep pace with the coronavirus' evolution. Pemgarda is engineered from adintrevimab, though.

Invivyd was launched in the early days of the COVID-19 pandemic under its prior name, Adagio Therapeutics.

With the authorization in hand, the company is looking to further explore the protective clinical benefits of monoclonal antibodyprophylaxis for symptomatic COVID-19, Hering said.

The company hadsome $200.6 million in cash and cash equivalents as of December 31, 2023.

Back in February, the company sold shares of its common stock for $40.5 million to bolster its balance sheet ahead of the upcoming launch. The money should help to fund the drugmakers operations through this years fourth quarter.

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Invivyd's COVID prophylactic scores FDA emergency nod for people with weakened immune systems - FiercePharma