Pfizer is submitting its experimental pill for COVID-19 for U.S. authorization, setting the stage for a likely launch of the promising therapy in coming weeks.
The company’s antiviral is one of a handful of pills that have recently been shown to significantly cut hospitalizations and deaths among people infected with COVID-19.
If authorized by the Food and Drug Administration it could be a major step toward managing the pandemic, allowing patients to treat themselves at home.
FDA regulators will scrutinize company data on the safety and effectiveness of the drug, which will be sold as Paxlovid, before making a decision
Earlier, Pfizer Inc. signed a deal with a U.N.-backed group to allow other manufacturers to make its experimental COVID-19 pill.
The move could help make the treatment available to more than half of the world’s population.
In a statement on Tuesday, Pfizer said it would grant a license for the antiviral pill to the Medicines Patent Pool.
The agreement lets generic drug companies make the pill for use in 95 countries.
The deal excludes some large countries with manufacturing capacity.
But health officials say the fact that the deal was struck before Pfizer’s pill has been authorized anywhere could help end the pandemic more quickly.
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