FDA Grants Emergency Use Authorization for Pemgarda, COVID-19 Infusion Drug

In a significant move to bolster protections against COVID-19, the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Pemgarda, an infusion drug manufactured by Invivyd. This authorization is specifically for patients who are immunocompromised, offering a crucial line of defense against COVID-19 infection. The FDA emphasized in its announcement that this treatment is intended for individuals with "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."

The newly authorized drug, Pemgarda, has been approved by the FDA for use as pre-exposure prophylaxis (prevention) against COVID-19 in certain adult and adolescent populations, including individuals weighing at least 40 kilograms (approximately 88 lbs) and aged 12 and above. It is designed for those individuals with moderate-to-severe immune compromise due to medical conditions or immunosuppressive treatments, and who are unlikely to mount an adequate immune response to COVID-19 vaccination.

This authorization is a critical step in protecting vulnerable populations, including cancer patients and those patients who have undergone organ transplants, against infectious diseases during public health emergencies. By allowing the use of Pemgarda, the FDA aims to enhance the nation's public health defenses against COVID-19.

The FDA's EUA authority empowers the agency to facilitate the availability and use of medical countermeasures (MCMs) crucial for combatting various threats, including infectious diseases like COVID-19. This step is part of the FDA's ongoing efforts to respond swiftly and effectively to emerging health challenges.

Despite the imminent expiration of the COVID-19 Public Health Emergency, the FDA's authorization of treatments for emergency use is not affected. The agency affirms that existing EUAs for products will continue in effect, and new EUAs may be issued as needed based on evolving circumstances and public health needs.

This targeted authorization of Pemgarda offers a significant advancement in the arsenal of tools available to combat the ongoing COVID-19 pandemic. The FDA's authorization of Pemgarda is a pivotal step forward in protecting vulnerable populations and reducing the impact of the virus on individuals with compromised immune systems. This development underscores the agency's commitment to swift action and innovative solutions in the face of public health emergencies.

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