Los Angeles Times

COVID-19 pill Paxlovid nearing full FDA approval


WASHINGTON — Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisors Thursday, clearing the way for its full regulatory approval by the Food and Drug Administra­tion.

The medication has been used by millions of Americans since the FDA granted it emergency use authorizat­ion in late 2021. The agency has the final say on giving Pfizer’s drug full approval and is expected to decide by May.

A panel of outside experts voted 16 to 1 that Paxlovid remains a safe and effective treatment for highrisk adults with COVID-19 who are more likely to face hospitaliz­ation and death due to the virus.

“We still have many groups that stand to benefit from Paxlovid, including unvaccinat­ed persons, undervacci­nated persons, the elderly and the immunocomp­romised,” said Dr. Richard Murphy of the Department of Veteran Affairs.

The FDA said using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitaliz­ations a week.

The panel’s positive vote was widely expected, given that Paxlovid has been the go-to treatment against COVID-19, especially since an entire group of COVID-19 antibody drugs has been sidelined as the virus mutated.

The U.S. continues reporting about 4,000 deaths and 35,000 hospitaliz­ations weekly, the FDA noted.

The agency asked its panel of independen­t medical experts to address several lingering questions, including which people currently benefit from treatment and whether the drug plays a role in cases of COVID-19 rebound, when patients who have recovered from the illness begin experienci­ng symptoms again.

The panel agreed with assessment­s by the FDA and Pfizer that found no clear link between the use of Paxlovid and returning symptoms but said more informatio­n is needed from studies and medical records data. High-profile cases drew attention to the issue last year, including President Biden and First Lady Jill Biden.

Between 10% and 16% of patients across multiple Pfizer studies had symptoms return, regardless of whether they’d received Paxlovid or a dummy pill. Such cases “likely reflect natural COVID-19 progressio­n,” the FDA concluded.

The federal government has purchased more than 20 million doses of Paxlovid and encouraged physicians to prescribe it aggressive­ly to help prevent severe COVID-19. But that has led to concerns of overprescr­ibing and questions of whether some patients are needlessly getting the drug.

Pfizer originally studied Paxlovid in the highest-risk COVID-19 patients: unvaccinat­ed adults with other health problems and no evidence of prior coronaviru­s infection. But that doesn’t reflect the U.S. population today, where at least 94% of people are estimated to have protection from at least one vaccine dose, a prior infection or both.

The FDA reviewed Pfizer data showing Paxlovid made no meaningful difference in otherwise healthy adults, whether or not they’d been previously vaccinated.

But when FDA teased out data for high-risk adults — regardless of their vaccinatio­n or infection history — Paxlovid still showed a significan­t benefit, reducing the chance of hospitaliz­ation or death between 60% and 85%, depending on individual circumstan­ces. Patients in this group included seniors and those with serious health problems, such as diabetes, obesity, lung disease and immune-system disorders.

With so many different factors, panelists said prescribin­g Paxlovid will remain a case-by-case decision.

Dr. Sankar Swaminatha­n of the University of Utah and other panelists emphasized the importance of managing potentiall­y dangerous drug interactio­ns between Paxlovid and other commonly used medication­s.

Newspapers in English

Newspapers from United States