Pfizer announced Tuesday it submitted an application to the Food and Drug Administration (FDA) for emergency use authorization of its oral coronavirus pill.
The submission includes data from the US pharmaceutical company's latest trials, for which the firm said on Nov. 5 its pill, PAXLOVID, reduces the risk of hospitalization or death from the virus by 89%.
If authorized PAXLOVID would be the first oral antiviral of its kind, specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, the firm said in a statement.
So far, all FDA authorized treatments for the virus require an intravenous injection under the supervision of health professionals at hospitals and clinics.
"With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options," Chairman and CEO Albert Bourla said in the statement. "We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the US FDA on its review of our application, along with other regulatory agencies around the world.”
Pfizer said earlier Tuesday it signed a licensing agreement with Unitaid-backed international organization Medicines Patent Pool allowing other drug makers to produce its COVID-19 antiviral treatment in 95 low- and middle-income countries, which account for approximately 53% of the world’s population.
The company noted it started investing up to $1 billion to support the manufacturing and distribution of the pill.
Pfizer is the second company in the world to develop a pill to treat the virus after Merck's oral antiviral treatment drug, Molnupiravir, was announced Oct. 1.
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