FDA Approves First COVID Pill

Regulators call Pfizer's Paxlovid pill a 'major step forward' in fight against pandemic
By Newser Editors and Wire Services
Posted Nov 16, 2021 6:44 PM CST
Updated Dec 22, 2021 12:47 PM CST
Pfizer Asks US Officials to OK COVID Pill
This image provided by Pfizer shows its COVID-19 pills.   (Pfizer via AP)

Update: The FDA has approved the first pill to treat COVID-19 at home—and not a moment too soon. Pfizer's Paxlovid antiviral pill was initially seen as an extra drug in the anti-COVID arsenal, but with cases surging and antibody treatments not working against the omicron variant, the pills are now urgently needed, the Washington Post reports. FDA officials described the drug as "a major step forward in the fight against this global pandemic," per NPR. Paxlovid is taken orally twice a day for five days in combination with another antiviral. Pfizer says it cuts the risk of hospitalization or death by 89% in high-risk patients when taken within three days of symptoms appearing. Our story from Nov. 16 follows:

Pfizer asked US regulators Tuesday to authorize its experimental pill for COVID-19, setting the stage for a likely launch this winter of a promising treatment that can be taken at home. The company's filing comes as new infections are rising once again in the United States, driven mainly by hot spots in states where colder weather is driving more Americans indoors, the AP reports. Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.

"We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients," Pfizer CEO Albert Bourla said in a statement. Specifically, Pfizer wants the drug available for adults who have mild-to-moderate COVID-19 infections and are at risk of becoming seriously ill. That's similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic. The FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. It’s not yet known whether Pfizer’s drug will undergo a similar public review.

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Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren't part of the initial tests. For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. (Pfizer signed a deal Tuesday to allow generic drugmakers to produce low-cost versions of the pill for certain countries.)

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