Pfizer is asking federal regulators to authorize its experimental COVID-19 pill, which the drugmaker says can defend folks from probably the most extreme signs of the illness.
Pfizer on Tuesday mentioned it’s looking for Emergency Use Authorization for the antiviral pill, referred to as Paxlovid, from the Meals and Drug Administration. Earlier this month, the corporate mentioned Pavlovid lower the danger of hospitalization and dying by almost 90% in folks with gentle to reasonable coronavirus infections.
The pharmaceutical big, which additionally produces a coronavirus vaccine, earlier on Tuesday introduced that it has signed a cope with a U.N.-backed group to permit different producers to make the COVID-19 pill, a transfer that would make the therapy out there to greater than half of the world’s inhabitants.
“The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” Pfizer CEO Albert Bourla mentioned in an announcement.
Pfizer mentioned it will grant a license for the antiviral pill to the Geneva, Switzerland-based Medicines Patent Pool, which might let generic drug firms produce the pill for use in 95 international locations, making up about 53% of the world’s inhabitants.
Different drugmakers are additionally growing a pill to deal with COVID-19. An FDA panel is scheduled to meet on November 30 to weigh a possible emergency use authorization for molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that lately received authorization in the UK.
Merck says its drug, referred to as molnupiravir, halved the danger that grownup COVID-19 sufferers with underlying well being situations ended up within the hospital or died from the illness.
Each Merck’s and Pfizer’s antiviral medicine are swallowed in capsules for 5 days beginning quickly after higher-risk sufferers take a look at constructive for the virus. Each capsules are designed to cut back the danger of extreme illness within the early days after an infection, however they work in numerous methods.
Pfizer says its pill halts the virus from spreading in an individual’s physique by deploying a brand new compound that may bind to an enzyme of the virus, blocking it from replicating inside contaminated cells. Merck’s drug, based mostly on a drug first developed at Emory University to fight the flu, tries to harness the physique’s cells to block the the virus from replicating.
Paxlovid works equally to remdesivir, an antiviral drug permitted by the FDA final 12 months to deal with COVID-19. However the capsules could be simpler to administer as a result of remdesivir have to be given as an I.V. in a hospital or clinic.
— With reporting from CBS Information’ Alexander Tin
