This is the second Covid-19 antiviral pill authorized for ill people to take at home, before they get sick enough to be hospitalized. Merck has an agreement with the US government for the company to supply 3.1 million courses of molnupiravir upon this authorization.
Molnupiravir was narrowly recommended by the FDA’s advisers in a 13-10 vote at the end of November after data showed it cut the risk of hospitalization or death by 30% among high-risk adults. This was lower than an earlier analysis suggesting that number could be about 50%.
Dr. Eliav Barr, senior vice president of global medical affairs at Merck, told CNN this month that he was optimistic this treatment would work against the Omicron variant.
“The Omicron variant is primarily different from the other types of Covid at the spike protein. Our drug works in completely different part of the virus. So we’re very optimistic that the drug will continue to be effective against Omicron, and we’re studying that right now.”
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.
Last week, Pfizer released updated results that showed the treatment cut the risk of hospitalization or death by 89% if given to high-risk adults within a few days of their first symptoms. If given within the first five days of symptoms, the efficacy was similar: 88%.
“Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” Pfizer Chairman and CEO Albert Bourla said in a statement. “Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”
He called Paxlovid a “potentially powerful tool in our fight against the virus, including the Omicron variant,” but stressed that getting vaccinated and receiving a booster shot remained “the most important tools we have to save lives.”
The FDA emphasized in a statement that Paxlovid is not for pre- or post-exposure prevention of Covid-19 and “is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
Separately, Merck has requested emergency use authorization for its antiviral pill, molnupiravir. It was narrowly recommended by FDA’s advisers in a 13-10 vote at the end of November after data showed it cut the risk of hospitalization or death by 30% among high-risk adults. This was lower than an earlier analysis suggesting that number could be around 50%. The FDA has not announced whether it will authorize the treatment.
Remdesivir, sold under the brand name Veklury, is the only antiviral approved by FDA for treatment of Covid-19. It’s given intravenously, not as a pill that can be taken at home.
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