FDA authorizes new drug to protect immune compromised from Covid-19

The Food and Drug Administration on Friday authorized a new antibody to protect immunocompromised individuals against Covid-19. 

The drug, known as Pemgarda and marketed by the biotech Invivyd, is the first such drug to become available since the agency pulled AstraZeneca’s Evusheld off the market in January 2023. New Omicron variants had rendered Evusheld ineffective.

Some immunocompromised patients — a group that includes certain cancer patients, patients with some autoimmune or genetic disorders, and organ transplant recipients — have been eagerly awaiting the new prophylactic. Because their condition or drugs they take for it weaken their immune systems, they don’t always get adequate protection from vaccination. Antibody treatments can add additional protection. 

There remains a need for additional Covid protections. Last week, over 10,000 patients with Covid-19 were admitted to U.S. hospitals. 

Still, it’s not clear how many patients will avail themselves of the new treatment. Invivyd, the drug’s developer, estimated there are 9 million immunocompromised people in the U.S., but its initial focus will be on the 485,000 with the most acute need: Stem cell transplant recipients, organ transplant recipients, and blood cancer patients.

Evusheld itself had gone vastly underused when it was available, prompting the federal government to launch efforts to educate the public about its existence. And the need is probably less acute now for some: Although immunocompromised patients have a reduced response to vaccination, many may still gain some protection from multiple rounds of vaccination and exposure to the virus. Uptake for other measures to mitigate Covid risk, such as boosters and Paxlovid upon infection, has also declined precipitously, despite public health efforts. 

“We will explore having it available at our institution, so that our very compromised patients and the services and specialities that take care of those patients know that it’s an option,” said Priya Nori, an infectious disease specialist at Albert Einstein College of Medicine. “But we’re not expecting gangbusters in terms of interest.”

Invivyd has not yet disclosed a price. 

The company was originally founded in 2020 by antibody expert Tillman Gerngross, under the name Adagio, and raised $309 million in an IPO a year later. But the company’s original antibody — which had been designed to be all but variant-proof — was soon rendered ineffective by the advent of Omicron, eventually leading to Gerngross’s resignation and a series of high-level changes at the company.

Pemgarda is a re-engineered version of the original antibody, designed to cover Omicron variants. That gave Invivyd a faster path to getting a new preventative on the market than competitors who started from scratch.