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

The four years since the start of the COVID-19 pandemic have yielded many advances against the coronavirus, including Moderna and Pfizer’s 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, Invivyd’s 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 adequate response to COVID-19 vaccination, the company said in a press release.

Previously, AstraZeneca's Evusheld gained an FDA endorsement for PrEP use in immunocompromised people, but it was later withdrawn.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, Inivyd’s CEO Dave Hering said in the company's release.

It’s been long known that the virus disproportionally impacts those who are immunocompromised, causing a higher rate of 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's debut is timely.

The FDA endorsed the therapy after Invivyd ran an immunobridging study 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 adintrevimab because 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 antibody prophylaxis for symptomatic COVID-19, Hering said.

The company had some $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 drugmaker’s operations through this year’s fourth quarter.