"FDA Approves PEMGARDA™ for COVID-19 Prevention in Immunocompromised"

The FDA has authorized a new antibody treatment, Pemgarda, to protect immunocompromised individuals from Covid-19, following the withdrawal of AstraZeneca's Evusheld due to its ineffectiveness against new Omicron variants. This drug is particularly important for immunocompromised patients who may not receive adequate protection from vaccination due to weakened immune systems. While there is a need for additional Covid-19 protections, it remains uncertain how many patients will opt for this new treatment. Invivyd, the drug's developer, estimates there are 9 million immunocompromised people in the U.S., with an initial focus on those with the most acute need. Pemgarda is a re-engineered version of the original antibody, designed to cover Omicron variants, and has been granted emergency use authorization by the FDA.
- FDA authorizes new drug to protect immune compromised from Covid-19 STAT
- New Monoclonal Authorized to Prevent COVID in Immunocompromised People Medpage Today
- Invivyd Shares Give Back Some Gains After Surge From FDA Emergency Approval MarketWatch
- Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19 GlobeNewswire
- FDA Roundup: March 22, 2024 | Nation & World | djournal.com Northeast Mississippi Daily Journal
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