Pfizer files for US license to treat COVID-19 – National

Pfizer Inc on Tuesday said it was seeking US authorization for its experimental antiviral drug. COVID-19 The pill reduced the chance of hospitalization or death by 89% for adults at risk of severe illness in a clinical trial.


Pfizer said it has completed the filing of an emergency use authorization (EUA) application for Paxlovid with the US Food and Drug Administration, including data from the manufacturer’s clinical trial. drug export.

Oral medication could be a promising new weapon in the fight against the pandemic, as it can be used as an early home treatment to help prevent COVID-19 death and recurrence. It could also become an important tool in countries and regions with limited vaccine access or low vaccination rates.

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Company says new Pfizer COVID-19 pill cuts risk of hospital death by 90%

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It remains unclear when US regulators will issue a ruling on Pfizer’s application. Merck & Co Inc and Ridgeback Biotherapeutics, which are developing a competing drug, molnupiravir, completed their EUA submission on Oct.

A panel of FDA external advisors will meet to review that application on November 30, and is expected to be available this year.

“We are moving as quickly as possible in our efforts to get this potential treatment into the hands of patients, and we look forward to working with the US FDA on the review of our application, along with other regulatory agencies around the world,” Pfizer CEO Albert Bourla said in a press release.

The New York-based drugmaker says it has already begun the approval process in several countries including the UK, Australia, New Zealand and South Korea, and plans to make further international submissions. .

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Pfizer allows other companies to make its COVID-19 pill

Pfizer said earlier on Tuesday that it would allow generic manufacturers to supply its COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with the public health group. International Medicines Patent Pool (MPP). | Pfizer files for US license to treat COVID-19 – National


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