Pfizer Seeks Emergency Use Authorization From FDA For Investigational Covid-19 Treatment Pill

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Pfizer Inc. (PFE) on Tuesday submitted an application to the U.S. Food and Drug Administration for emergency authorization of its investigational Covid-19 treatment pill.

Pfizer said it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.

The company has submitted clinical data from the Phase 2/3 EPIC-HR interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

If FDA approves the EUA, PAXLOVID would be the first oral antiviral of its kind that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.

"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. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

According to Pfizer, the data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with PAXLOVID compared to placebo within three days of symptom onset, with no deaths in the treatment group.

Earlier Tuesday, Pfizer and the Medicines Patent Pool, a United Nations-backed public health organization, announced a deal that allowed generic pharma company to supply Paxlovid to 95 low and middle-income countries, covering up to approximately 53 percent of the world's population.

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