Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
The FDA declined to expand the emergency use authorization for Invivyd’s anti-SARS-CoV-2 bispecific antibody Pemgarda, the company said Monday.
Invivyd had applied for expanded use to include treatment of mild and moderate COVID-19 for immunocompromised persons without an alternative treatment option. The emergency use authorization (EUA) for Pemgarda as a pre-exposure prophylactic, which the company received from the FDA last March, is still in effect.
The Waltham, MA–based company made the announcement Monday morning. By Monday afternoon, Invivyd’s stock had lost about one-third of its value, falling from $1.77 per share at open to about $1.21 per share.
The news was perhaps not much of a surprise to analysts. “This outcome underscores the FDA’s insistence on superior antiviral activity for treatment indications and highlights the challenges of re-purposing monoclonal antibodies amid an evolving viral landscape,” Patrick Trucchio, an analyst with HC Wainwright, wrote in a note Monday.
Pemgarda is currently the only pre-exposure prophylactic for COVID-19 on the market. AstraZeneca’s Evusheld was approved in 2021 but was withdrawn from the market in 2023 when it lost its effectiveness against emerging SARS-CoV-2 variants.
Invivyd’s pipeline is mostly focused on antibody treatments and prophylaxis for COVID-19 as an alternative to vaccines for immunocompromised patients. While Pemgarda remains without a full FDA approval, the company is continuing a Phase I clinical trial on a next-generation antibody COVID-19 prophylactic, called VYD2311, which it sees as a successor to Pemgarda.
Invivyd announced promising initial data for VYD2311 earlier this month. “Deploying a new protective mAb in the future that has the convenience and scalability of current vaccine boosts but with substantially more attractive protection, safety, and durability [than Pemgarda] would be a massive step change in medical value for millions of Americans in need,” Invivyd Chief Commerical Officer Tim Lee said in a statement outlining that data.
