FDA approves Covid-19 mAb for emergency use

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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

It is approved in adults and adolescents (12 years of age and older weighing at least 40kg) who are moderate-to-severely immune compromised due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to Covid-19 vaccination.

The FDA says that recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

“People who are immunocompromised continue to be disproportionally impacted by Covid-19 even after receiving multiple vaccine doses,” said Cameron Wolfe, Professor of Medicine, Transplant Infectious Disease at Duke University School of Medicine. “I’m excited to have Pemgarda as an additional Covid-19 preventive option for moderately to severely immunocompromised adult and adolescent patients, such as solid organ transplant recipients and those with haematological malignancies. These types of patients, among others, continue to have both an impaired response to vaccines and a higher risk for severe Covid-19 outcomes.”

Clinical trial evidence for Pemgarda

The EUA of Pemgarda is based on scientific evidence, such as data showing that immunobridging was established in the CANOPY clinical trial and that the calculated serum neutralising antibody titers against JN.1 were consistent with the titer levels associated with efficacy in prior clinical trials of adintrevimab (ADG20), the parent mAb for VYD222, and other monoclonal antibody products.

JN.1 is currently the dominant variant circulating in the US according to estimates from the Centers for Disease Control and Prevention (CDC).

“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,” said Dave Hering, Chief Executive Officer of Invivyd.

Diana Spencer, Senior Digital Content Editor, DDW

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