Invivyd Plans Full FDA Approval for COVID-19 as PEMGARDA EUA Faces 2027 Expiration

The U.S. Food and Drug Administration has issued Invivyd a Notice of Termination for the Emergency Use Authorization (EUA) of PEMGARDA® (pemivibart) after the U.S. Department of Health and Human Services (HHS) announced plans to end the COVID-19 EUA declaration effective June 29, 2027. The decision follows HHS’s advance notice issued on June 30, 2026, providing a one-year transition period before COVID-19 EUA products lose authorization.

PEMGARDA has been available under an EUA since March 2024 for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older (weighing at least 40 kg) with moderate-to-severe immune compromise who are unlikely to mount an adequate immune response following COVID-19 vaccination. Unless a different regulatory pathway is established, the authorization will expire on June 29, 2027.

Invivyd Pursues Pathway to Full FDA Approval

Invivyd said it is actively discussing the next regulatory steps with the FDA and intends to pursue permanent approval for PEMGARDA. The company noted that, under Section 564 of the Federal Food, Drug, and Cosmetic Act, sponsors should receive guidance regarding potential approval pathways following EUA termination. According to Invivyd, it has not yet received specific regulatory recommendations regarding a Biologics License Application (BLA) for PEMGARDA.

PEMGARDA Provides Long-Acting COVID-19 Prevention for Immunocompromised Patients

PEMGARDA is a half-life extended monoclonal antibody derived from adintrevimab. It binds the receptor-binding domain of the SARS-CoV-2 spike protein, preventing viral attachment to the ACE2 receptor on host cells. Laboratory studies have shown neutralizing activity against multiple contemporary SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1, and XFG.

The EUA was supported using an immunobridging strategy that correlated serum neutralizing antibody levels with protection observed for previously authorized COVID-19 monoclonal antibodies, including adintrevimab. Although this approach enabled emergency authorization, the company argues that additional clinical and real-world evidence accumulated over the past two years now supports full regulatory approval.

Clinical Evidence and Safety Profile Support Continued Development

Clinical evidence for PEMGARDA includes data from the pivotal CANOPY study, together with post-authorization safety monitoring and expanding real-world clinical use. The therapy remains one of the few non-vaccine preventive options available for patients with significant immune compromise. However, the authorization continues to depend on circulating SARS-CoV-2 variants remaining susceptible to pemivibart, with use permitted only when resistant variants account for no more than 90% of national circulation.

PEMGARDA is administered as a 4,500 mg intravenous infusion and is authorized exclusively for pre-exposure prevention of COVID-19. It is not authorized for treatment of COVID-19, Long COVID, post-vaccination syndrome, or post-exposure prophylaxis. The prescribing information carries a boxed warning for anaphylaxis, while the most frequently reported adverse events include infusion-related reactions, hypersensitivity reactions, infusion-site reactions, and infusion-site infiltration or extravasation.

Regulatory Discussions Continue Ahead of June 2027 Deadline

Invivyd’s leadership said the transition away from the EUA framework should not interrupt access to effective preventive therapies for vulnerable patients. The company maintains that the combined evidence from randomized clinical studies and post-authorization experience supports submission of a BLA and plans to continue working with the FDA to establish an appropriate approval pathway before the EUA expires in June 2027.

Reference

Invivyd Announces Receipt of Twelve Months’ Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA – Invivyd