FDA revises Paxlovid emergency use authorization, allowing EUA-labeled Paxlovid use until March 8, 2024, shifting thereafter to NDA-labeled Paxlovid for treating mild-to-moderate COVID-19, ensuring continuity and safety.

United States: In December 2021, the FDA granted emergency use authorization (EUA) to Paxlovid for treating adults and pediatric patients aged 12 and above, weighing at least 40 kg, who faced a high risk of developing severe COVID-19, including hospitalization or death. Subsequently, in May 2023, Pfizer's new drug application (NDA) for Paxlovid was approved by the FDA for treating mild-to-moderate COVID-19 in high-risk adults.

On 29^th January 2024, the FDA has announced a revision to the Paxlovid EUA. According to the update, Paxlovid manufactured and labeled in accordance with the EUA, referred to as EUA-labeled Paxlovid, will remain authorized for use until its labeled or extended expiration date, or until March 8, 2024, whichever comes earlier.

After March 8, 2024, EUA-labeled Paxlovid will no longer be authorized for emergency use, regardless of its expiration date. However, the Paxlovid EUA will still allow for emergency use of Paxlovid manufactured and labeled as per the NDA (NDA-labeled Paxlovid) for treating mild-to-moderate COVID-19 in pediatric patients aged 12 and above, weighing at least 40 kg, who are at high risk of developing severe COVID-19.

This update signifies the progression from the use of EUA-labeled Paxlovid to NDA-labeled Paxlovid. The transition commenced on November 1, 2023, with the introduction of FDA-approved Paxlovid (NDA-labeled Paxlovid).

To ensure continued availability of Paxlovid and facilitate a smooth transition to FDA-approved Paxlovid, information regarding the timing of the shift from EUA-labeled Paxlovid to NDA-labeled Paxlovid is provided in the revised authorization. This allows dispensing sites, such as pharmacies, that have not yet transitioned to NDA-labeled Paxlovid adequate time to do so.

Patients with a prescription for Paxlovid will receive either EUA-labeled or NDA-labeled Paxlovid until March 8, 2024. Following this date, they will exclusively receive NDA-labeled Paxlovid.

Patients who are prescribed EUA-labeled Paxlovid on or before March 8, 2024, and have commenced treatment by that date, will be permitted to complete their treatment course even if it extends beyond March 8, 2024.

This adjustment in the Paxlovid EUA reflects the FDA's ongoing assessment and management of COVID-19 therapeutics, ensuring appropriate access to treatments while upholding safety standards and transitioning to approved medications.

According to TechSci Research, the revision to the Paxlovid emergency use authorization (EUA) by the FDA significantly impacts both the healthcare and pharmaceutical markets, introducing changes that necessitate adaptation and strategic planning from various stakeholders. The transition from EUA-labeled Paxlovid to NDA-labeled Paxlovid marks a pivotal moment for healthcare providers and facilities. As the authorization for EUA-labeled Paxlovid expires after March 8, 2024, healthcare institutions must ensure a smooth transition to the FDA-approved NDA-labeled Paxlovid. This entails updating protocols, adjusting inventory management systems, and training staff to administer the newly authorized medication effectively. Any delays or challenges in this transition could potentially disrupt patient care and strain healthcare resources.

Moreover, the shift to NDA-labeled Paxlovid carries implications for pharmaceutical companies, particularly Pfizer, the manufacturer of Paxlovid. With the expiration of the EUA for Paxlovid, Pfizer will likely experience changes in demand and distribution patterns for the medication. The company must adjust production schedules, supply chains, and marketing strategies accordingly to meet the evolving needs of the market. Additionally, Pfizer may face competition from other pharmaceutical companies developing similar COVID-19 treatments, necessitating ongoing research and development efforts to maintain competitiveness in the market.

Furthermore, the revision to the Paxlovid EUA underscores the importance of regulatory compliance and adherence to safety standards in the pharmaceutical industry. As the FDA continues to monitor and update emergency use authorizations based on evolving scientific evidence and public health needs, pharmaceutical companies must demonstrate the efficacy and safety of their products through rigorous clinical trials and regulatory processes. This emphasizes the significance of transparency, collaboration, and adherence to regulatory guidelines in ensuring the availability of safe and effective treatments for patients.