In an anticipated move, Pfizer (PFE) chief executive officer Albert Bourla said the company plans to ask the U.S. Food and Drug Administration on Tuesday to authorize emergency use of its antiviral pill for combating Covid-19.
Bourla announced the company’s intention to file the application earlier than expected at the 2021 STAT Summit. The step comes shortly after the company reported its pill, called Paxlovid, reduced hospitalizations by 89% among patients who started within three days of symptoms and also prevented deaths in a large, randomized study. The disclosure followed news from Merck (MRK) that its own pill reduced hospitalizations by 50%, although data was not shared on patients treated within three days of symptoms.
While neither drug maker has released complete study data, the one-two punch of top-line announcements generated considerable enthusiasm that helpful tools may finally become available to tame the coronavirus, which has claimed more than 760,000 lives in the U.S., according to the Centers for Disease Control and Prevention.
advertisement The Pfizer pill is given as a five-day course, and must be combined with a second medicine called ritonavir, which is made by AbbVie (ABBV). The Pfizer regimen involves taking 30 pills over a five-day period. For now, the cost is unclear, although Pfizer has signaled it will sell its treatment directly at a price comparable to what Merck charges for its own pill, which sells for as much as $750 in Japan. Elsewhere, though, Pfizer has signed a licensing agreement with the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide generic versions of the drug to 95 low and middle-income countries. The pricing will be determined by the generic companies, but the move comes amid mounting on pressure on drug makers to widen global access to Covid-19 medical products.
advertisement Meanwhile, Pfizer has suggested its pill may eventually be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults. However, it is worth noting that ritonavir can cause serious interactions when combined with other medicines. This name will appear with your comment
https://www.statnews.com/pharmalot/2021/11/16/pfizer-covid19-bourla-pill-paxlovid-fda/
