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FDA grants emergency use authorization for COVID-19 drug

Pemgarda, made by Invivyd, is an infusion drug approved for use by patients who are immunocompromised to help protect against COVID-19 infection.
FDA grants emergency use authorization for COVID-19 drug
Posted at 3:57 PM, Mar 26, 2024

There’s a new drug to help the fight against COVID-19.

Pemgarda, made by Invivyd, is an infusion drug made for those who are immunocompromised to help support the immune system in preventing COVID-19 infection.

The Food and Drug Administration granted an emergency use authorization for high-risk patients 12 years and older on March 22. Individuals must also weigh 88 pounds to use the drug.

The FDA wrote in the announcement that this treatment is authorized for those who “have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.”

This could include cancer patients or those who received an organ transplant, for example.

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Qualified individuals can get the monoclonal antibody infusion once every three months at most.

No cost was mentioned in the company’s press release.

Pemgarda is not meant as a treatment for those who currently have COVID-19 or have been recently exposed to the disease.

The drug will be available in the coming weeks; however, since it's only authorized for emergency use, it is not fully approved by the FDA.

The National Institutes of Health has recommended against the use of monoclonal antibodies for the treatment or prevention of COVID-19.

For more information on COVID-19 monoclonal antibody treatments and where they stand with the FDA, you can visit this page from the Centers for Medicare & Medicaid Services.

SEE MORE: 4 years since the COVID pandemic lockdown: How it changed our lives


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