New COVID-19 preventative Pemgarda authorized for immunocompromised

The U.S. Food and Drug Administration (FDA) has issued its first emergency use authorization (EUA) for a monoclonal antibody (mAb) to prevent COVID-19 since Evusheld’s EUA was pulled in early 2023. Pemivibart, marketed under the trade name Pemgarda, is made by Invivyd and is meant to be used before exposure to prevent COVID-19 in those who are at least 12 years of age, weigh at least 88 pounds, and are moderately to severely immunocompromised. 

“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 (IDF) and a steering committee member of the Immunocompromised Collaborative. “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.”

Many people who are immunocompromised, including some with primary immunodeficiencies (PIs), do not respond to vaccines. COVID-19 vaccines are active immunizations that require the recipient’s immune system to generate protective antibodies, whereas Pemgarda provides passive protection no matter the status of a person’s immune system. The FDA stressed that Pemgarda is not meant to be a substitute for vaccination against COVID-19 and that only those who are likely to have a poor response to vaccines should receive it. Pemgarda is also not authorized to treat COVID-19 or to act preventatively once someone has been exposed to COVID-19.

The mAb is given as a single intravenous (IV) infusion in a healthcare setting equipped to monitor recipients for adverse reactions such as anaphylaxis. Like Evusheld, Pemgarda has been modified to extend the life of the antibody in a person’s bloodstream but will need to be re-dosed every three months to maintain protection.

Invivyd pursued a unique ‘immunobridging’ strategy to gain authorization for Pemgarda from the FDA. Prior to the rise of the Omicron variant, Invivyd developed a mAb meant to compete with AstraZeneca’s Evusheld. However, midway through clinical trials, laboratory experiments showed that Invivyd’s mAb could not neutralize the quickly rising Omicron variant. Evusheld’s EUA was revoked because of its lack of activity against Omicron as well. In talks with the FDA, Invivyd argued that data from those trials could be used to support Pemgarda’s authorization since it is derived from that mAb candidate, uses the same manufacturing platform, and is functionally similar. The FDA agreed, significantly shortening the development process for Pemgarda.

Invivyd continues to monitor Pemgarda’s neutralizing activity against new COVID-19 variants as they arise and has shown that it maintains activity against JN.1, which is currently the dominant variant circulating in the U.S.