FDA authorizes pre-exposure prophylaxis for COVID-19

Invivyd was granted an Emergency Use Authorization by the United States FDA for PEMGARDA, a pre-exposure prophylaxis (PrEP) treatment for COVID-19. The administration is authorizing the therapy for moderately to severely immunocompromised patients.

PEMGARDA, known as pemivibart and previously called VYD222, is a half-life extended monoclonal antibody engineered from adintrevimab. The drug, administered as a 4,500 mg intravenous injection, neutralizes SARS-CoV-2 variants, including JN.1, by targeting the virus’s spike protein receptor binding domain, inhibiting viral attachment to host cells.

“The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the US. This EUA milestone represents strategic proof-of-concept for our company and platform, affirming the unique strategy we embarked on over a year ago: to use rapid innovation and surrogate markers to bring new antibodies to market repeatedly,” said Dave Hering, Chief Executive Officer of Invivyd, in the company’s press release.

The authorization was based on the clinical trial data from the CANOPY study, an ongoing phase 3 clinical trial testing the product.

The study includes two cohorts. Cohort A includes 306 moderately to severely immunocompromised adults enrolled in a single-arm, open-label trial. Meanwhile, cohort B enrolled 479 moderately to severely immunocompromised patients randomized in a placebo-controlled clinical trial. Two-thirds of the patients received PEMGARDA, while one-third received a placebo.

By quantifying serum virus neutralizing antibodies (sVNA), the researchers proved the drug’s ability to neutralize SARS-CoV-2 variants.

“COVID-19 continues to pose a significant threat and major concern to those who are moderately to severely immunocompromised,” said Jorey Berry, President and CEO of the Immune Deficiency Foundation and a steering committee member of the Immunocompromised Collaborative, in the Invivyd press release. “As such, we are delighted that a new monoclonal antibody for pre-exposure prophylaxis of COVID-19 will be available soon for certain vulnerable populations.”

PEMGARDA is now authorized for 306 moderately to severely immunocompromised individuals 12 and older with no recent exposure to SARS-CoV-2 who do not have a history of severe allergic reactions to the components of the product.