Pfizer Applies for FDA Emergency Approval of COVID-19 Oral Treatment Pill

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] On the 16th (local time), U.S. pharmaceutical company Pfizer applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization of the oral COVID-19 treatment Paxlovid. Paxlovid is expected to become the second oral COVID-19 treatment following Merck's molnupiravir.

Albert Bourla, CEO of Pfizer, said in a statement on the day, "There is an urgent need for life-saving treatments," adding, "We are moving as quickly as possible to provide this treatment to patients."

Paxlovid is an oral antiviral in pill form, and Pfizer's own clinical trial results showed that taking it within three days of symptom onset reduced the risk of hospitalization and death by up to 89%.

As the Biden administration is expected to officially announce plans to purchase 10 million doses of Paxlovid this week, FDA approval is anticipated within the year.

In addition, prior to the FDA application, Pfizer signed a licensing agreement with the United Nations-supported medical organization, the International Medicines Patent Pool (MPP), allowing the manufacture of generic versions of this treatment in 95 low- and middle-income countries.

As a result, this treatment will be available royalty-free in countries where more than half of the world's population resides. An MPP official stated, "We plan to partner with at least 12 pharmaceutical companies to supply it affordably to low- and middle-income countries."

This content was produced with the assistance of AI translation services.