First oral antiviral treatment for COVID-19 receives FDA approval

Pfizer’s paxlovid (nilmatrelvir and ritonavir tablets), an oral antiviral drug for the treatment of COVID-19, will be available from December 2021 under FDA Emergency Use Authorization (EUA) However, the FDA granted full approval on May 25.

Paxlovid is the first oral antiviral treatment for mild to moderate COVID-19 in adults at high risk of progression to severe COVID-19, including hospitalization and death, Pfizer said. More than 11.6 million courses of treatment have been prescribed in the United States so far, according to the manufacturer.

Pfizer said the U.S. government will continue to oversee the distribution of Paxrobid, and eligible U.S. residents of the drug will continue to receive the drug free of charge.

“Today’s approval confirms that paxlovid has met the agency’s stringent standards for safety and efficacy, and that it has progressed to severe COVID-19, including those who were previously immune. It shows that it remains an important treatment option for people at high risk,” said Dr. Patrizia Cavazzoni. , Director of the FDA Center for Drug Evaluation and Research. “FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19.”

Pfizer Chairman and CEO Albert Bourra said that despite “great progress” in fighting COVID-19, the virus remains “an unpredictable concern at this time.” said it is. “This is especially true for the hundreds of millions of American adults over the age of 50, or those who are at high risk of developing severe disease, even if their symptoms were mild at first.”

FDA approval is based on a body of scientific evidence shared by Pfizer, including safety and efficacy data from the EPIC clinical development program. This includes the Phase 2/3 EPIC-HR study enrolling adults 18 years of age or older with confirmed COVID-19 who are not vaccinated, who are not hospitalized, and who are at high risk of developing severe disease. Contains results.

Data show an 86% reduction in risk of COVID-19-related hospitalization or death from any cause by day 28 compared to placebo in patients who started treatment with paxlobid within 5 days of symptom onset , Pfizer said.

In addition, a secondary endpoint of the Phase 2/3 EPIC-SR trial evaluated COVID-19-related hospitalization or death from any cause by day 28 in the non-hospitalized adult subgroup aged 18 years and older. was shown to decrease numerically. , People with confirmed COVID-19 who have at least one risk factor for severe disease and who are fully vaccinated.

In addition, Paxlovid’s recent real-world study supports efficacy conclusions from Pfizer’s EPIC clinical program, in a post-approval setting where the Omicron sublineage predominates and high levels of pre-existing immunity are occurring. We provide additional data on the use of paxlovid. According to Pfizer. “These studies showed that paxlovid was effective in both vaccinated and unvaccinated high-risk patients,” the company said.

According to Pfizer, the FDA announced in March that more than 1,500 lives could be saved and 13,000 hospitalizations avoided each week using paxlobid in targeted patients.

The research arm of Epic, an electronic health record company headquartered in Verona, Wisconsin, shared the results of a Pfizer study last year that found that hospitalizations and deaths were significantly higher in patients treated with paxlovid versus those not treated with paxlovid. showed a difference. I was vaccinated.

The difference was larger for those aged 65 and over. But Epic’s research found differences even in the 50-64 age group. For example, among 20,407 people of the same age who were treated with paxlovid, fully vaccinated and boosted, there were 27 hospitalizations (0.13%) and no deaths.

Of 38,689 adults in the fully vaccinated booster group who did not receive paxlovid treatment, 143 (0.37%) were hospitalized and 7 (0.02%) died. This translates into almost three times higher hospitalization rates for patients not treated with paxlovid compared to treated patients.

Meanwhile, Pfizer continues to collect pediatric data from its ongoing EPIC-Peds clinical trial and plans to submit a supplemental new drug application (sNDA) in the future to support FDA approval of paxlovid for children.

A Pfizer spokeswoman said that at this time, the U.S. government will continue to oversee the distribution of paxlobid and that eligible U.S. residents will continue to receive the drug free of charge (other administrative fees apply). sometimes) said. Pfizer plans to bring Paxlovid to market later this year, but the timing will depend on a number of factors, including USG’s existing supply of Paxlovid.

“We look forward to continuing to work with payers to ensure timely and equitable access to Paxlobid for eligible U.S. patients,” the spokesperson said. “Ultimately, patient copays vary and are determined by insurance companies.

The FDA said the Paxlovid label of approval and the Paxlovid EUA approval fact sheet for healthcare providers come with a boxed warning containing instructions for prescribers. “The prescriber should review all medications the patient has taken to assess potential drug interactions and adjust, interrupt, and/or add doses to other medications the patient may be taking. Prescribers should consider the benefits of paxlobid treatment in reducing hospitalizations and mortality and whether the risk of potential drug interactions in individual patients can be adequately managed. We have to,” the official said.

This article originally appeared in Formulary Watch.

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