Pfizer asked the Food and Drug Administration (FDA) on Tuesday to authorize its experimental Covid-19 antiviral treatment, Paxlovid. Experts say an antiviral pill for Covid would have a major impact on the pandemic by making treatment available at home, without an injection or IV. Pfizer says the pill lessens the risk of severe disease in vulnerable adults. The company also announced earlier on Tuesday that it had signed a deal with a U.N.-backed group to allow other drug manufacturers to make the pill, which could make the drug available to more than half of the world’s population.
Paxlovid works by preventing the coronavirus from replicating inside cells. It combines two antivirals: an experimental compound called PF-07321332 and an existing drug called ritonavir, which is used in treating HIV. Pfizer’s regimen consists of three pills taken twice daily for five days. It is meant to be given early, within three to five days of symptoms. The treatment was shown in clinical trials to reduce the risk of hospitalization and death by 89 percent in people at high risk of severe illness, the company reported this month, though the full data has not been made public for scientists to review.
WASHINGTON (AP) — Pfizer asks US regulators to authorize COVID-19 pill that reduces deaths, hospitalizations.
— Kyle Griffin (@kylegriffin1) November 16, 2021
Pfizer said in a statement that the treatment is safe, and that side effects were mild and occurred at the same rate as in the placebo group. It did not detail what the side effects were. While Pfizer isn’t the first company to ask the FDA to authorize an antiviral pill for Covid, they may be the first to hit the market. In October, Merck and its partner Ridgeback Biotherapeutic applied for authorization of an antiviral. An FDA advisory committee will review that request on November 30th.
NEW: Pfizer has asked the FDA to authorize its COVID-19 pill, the company has announced in a press release.
Both Merck and Pfizer are working on pills that appear very effective at keeping patients out of the hospital, according to the companies. https://t.co/8Olo2Kc2iH
— ABC News (@ABC) November 16, 2021
Pfizer will not receive royalties on sales in lower-income countries and said it would waive royalties in all nations included in the agreement while Covid remains a World Health Organization-designated public health emergency.
BREAKING: Pfizer files for U.S. authorization of its experimental COVID-19 pill, which cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial https://t.co/vMnnTxm4Lf pic.twitter.com/Cfqp0qZ4q4
— Reuters (@Reuters) November 16, 2021