Pfizer requests FDA emergency use authorization for its COVID-19 pill

By Carolyn Crist

Pfizer has signed an agreement to allow other manufacturers to produce its experimental COVID-19 pill, potentially opening access to the treatment to countries around the world.

On Tuesday, the company said it would license the pill to the Medicines Patent Pool, a UN-backed group based in Geneva, Switzerland. The agreement would allow generic drug companies to produce the pill for use in 95 countries, covering approximately 53% of the world's population, according to a press release.

"It's quite significant that we can provide access to a drug that appears to be effective and that has just been developed to more than 4 billion people," Esteban Burrone, chief policy officer of the Drug Patent Fund, told The Associated Press.

Drug manufacturers could begin producing the pill within a few months, Burrone said.

But the agreement has some caveats and excludes some large countries from manufacturing the pill. Under the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties in all countries included in the agreement while COVID-19 remains a public health emergency, the AP reported.

"We try to strike a very delicate balance between the interests of the company, the sustainability required by generic drug producers and, most importantly, the public health needs in low- and middle-income countries," Burrone said.

Pfizer has said the pill reduces the risk of hospitalization and death by 89% among people with mild to moderate COVID-19 infections, according to a statement released this month. The company said it would soon seek FDA approval.

Researchers have been working to develop a pill to treat COVID-19 that people can easily take at home and avoid going to hospitals, the AP reported. Most COVID-19 treatments must be administered intravenously or by injection under medical supervision.

Earlier this month, Britain authorized a COVID-19 pill manufactured by Merck, which is awaiting approval in other countries. In October, the company signed a similar agreement with the Medicines Patent Pool to make its pill, called molnupiravir, available in 105 countries.

Following Pfizer's announcement, Doctors Without Borders told the Associated Press that it was "disheartened" because the agreement does not make the pill available in all countries. Specifically, the agreement excludes countries such as Argentina, Brazil, China, Russia, and Thailand. Merck's agreement also excludes countries such as Brazil, China, and Russia.

"The world now knows that access to COVID-19 medical tools must be guaranteed for everyone, everywhere, if we truly want to control this pandemic," said Yuanqiong Hu, PhD, senior legal policy advisor at Doctors Without Borders. AP.

Sources

The Associated Press: "Pfizer agrees to allow other companies to manufacture its COVID-19 pill."

Pfizer: “Pfizer and the Medicines Patent Fund (MPP) sign a licensing agreement for the COVID-19 oral antiviral treatment candidate to expand access in low- and middle-income countries,” “Pfizer’s new COVID-19 oral antiviral treatment candidate reduces the risk of hospitalization or death by 89% in the interim analysis of the Phase 2/3 EPIC-HR study.”

From: https://www.medscape.com/viewarticle/963061

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