FDA ending emergency use authorization for Paxlovid

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The Food and Drug Administration has set March 8 as the end of its emergency use authorization (EUA) for Paxlovid for adult patients, the agency has said this week. The medication is given to those considered high risk for progression to severe COVID-19, including hospitalization or death.

In May 2023, FDA approved Pfizer's new drug application (NDA) for Paxlovid for the treatment of mild-to-moderate COVID-19 in adults. Now, Paxlovid currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, or through March 8, whichever is earlier.

However, the Paxlovid EUA will continue to authorize emergency use of the drug for pediatric patients 12 years old and older and weighing at least 40 kg.

"This revision to the Paxlovid EUA is the next phase in the transition from the use of EUA-labeled Paxlovid to the use of NDA-labeled Paxlovid, the FDA said. "This transition began on November 1, 2023, with the introduction of FDA-approved Paxlovid."

The FDA said it's providing information on the timing of the shift from EUA-labeled Paxlovid to NDA-labeled Paxlovid so that pharmacies that have not yet made the transition have time to do so.

WHAT'S THE IMPACT?

EUA-labeled Paxlovid can still be dispensed to patients through March 8, with the FDA advising both providers and patients to consult Pfizer's website for information on batches of the drug that are subject to a shelf-life extension.

Expired EUA-labeled Paxlovid must be returned to the manufacturer or disposed of in accordance with federal, state and local regulations, the FDA said. Similarly, after March 8, all EUA-labeled Paxlovid remaining in U.S. distribution must also be returned to the manufacturer or disposed of.

After March 8, patients with a Paxlovid prescription will receive the NDA-labeled version of the medication. Patients who receive a prescription of EUA-labeled Paxlovid on or prior to March 8, and have initiated treatment before that date, can complete their course of treatment even that brings them beyond March 8.

Through December 31, 2024, eligible patients qualify for free Paxlovid through the PAXCESS program. Eligible patients include Medicare beneficiaries, Medicaid beneficiaries, and uninsured individuals who do not have a prescription drug benefit at the time they fill their prescription. Patients who are commercially insured may be eligible for assistance though a copay savings program.

THE LARGER TREND

The FDA originally issued an EUA for Paxlovid just before Christmas 2021. Importantly, the drug is not authorized for the prevention of COVID-19, or for treating those already requiring hospitalization due to severe or critical COVID-19. It's also not a substitute for vaccination in those for whom the shot and a booster dose are recommended.

According to the FDA, Paxlovid must be taken within five days of symptom onset in order for it to be effective. Because of that small window, the agency said authorizing state-licensed pharmacists to prescribe the drug could expand access to more people in the eligible population.

Data published by Pfizer in May of last year found Paxlovid proved ineffective at preventing coronavirus infection among people living in the same house as an infected person. While there were risk reductions of 32% and 37% in adults who had received Paxlovid for five and 10 days, respectively, the results were not statistically significant. It's a disappointing finding for a drug that sought to prevent infection from household contact.

While the finding is not what Pfizer had hoped, the company said the results don't impact the strong efficacy and safety data observed in an earlier trial that tested the drug's effect in preventing severe illness.
 

Jeff Lagasse is editor of Healthcare Finance News.
Email: jlagasse@himss.org
Healthcare Finance News is a HIMSS Media publication.