Infectious Disease Special Edition (IDSE)FDA Revises EUA for Paxlovid

Transitioning to FDA-Approved COVID-19 Treatment: A New Phase for Paxlovid

In a significant development for COVID-19 treatment, the FDA has revised the emergency use authorization (EUA) for nirmatrelvir+ritonavir (Paxlovid, Pfizer), marking a pivotal transition towards the utilization of the drug under a new drug application (NDA). This adjustment reflects the ongoing efforts to streamline treatment protocols and ensure the medication’s efficacy and availability for high-risk populations, amidst evolving regulatory landscapes. This strategic move not only underscores the importance of adapting to changing health emergencies but also emphasizes the critical role of regulatory oversight in ensuring patient safety and access to effective treatments.

Key Points:

• FDA Announcement: The FDA has revised the EUA for nirmatrelvir+ritonavir (Paxlovid) to extend its authorized use through the labeled or extended expiration date or until March 8, 2024, whichever comes first.
• EUA vs. NDA Labeled Product: Post-March 8, 2024, only nirmatrelvir+ritonavir manufactured and labeled under the NDA will be authorized for emergency use for treating mild to moderate COVID-19 in pediatric patients (≥12 years old and weighing ≥40 kg) at high risk for severe disease.
• Initial Authorization and FDA Approval: Initially authorized in December 2021 for emergency use in adults and children at high risk of severe COVID-19, the FDA approved Pfizer’s NDA for nirmatrelvir+ritonavir in May 2023 for adults in similar risk categories.
• Transition Strategy: The transition to NDA-labeled nirmatrelvir+ritonavir began on November 1, 2023, with the introduction of the FDA-approved product, aiming for a smooth shift and continuous availability at dispensing points.
• Dispensing Guidance: Until March 8, 2024, EUA-labeled nirmatrelvir+ritonavir can still be dispensed under the terms of the EUA, with providers and patients directed to Pfizer’s website for information on shelf-life extension.
• Post-Expiration Actions: After March 8, 2024, any remaining EUA-labeled product must be returned to the manufacturer or disposed of according to regulations.
• Treatment Completion Post March 8: Patients who start treatment with EUA-labeled nirmatrelvir+ritonavir by March 8, 2024, can complete their regimen even if it extends beyond this date.
• PAXCESS Program: Through December 31, 2024, eligible patients, including Medicare, Medicaid beneficiaries, and uninsured individuals, can access nirmatrelvir+ritonavir for free, with a copay savings program available for those with commercial insurance.

HCN Medical Memo
If your patients have been prescribed PAXLOVID, they may be eligible for support resources through PAXCESS so they can get their PAXLOVID prescription as soon as possible.

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