New Pfizer Covid-19 pill seeking emergency use authorization from FDA

COVID-19 pill
© Yaroslav Prokopenko

Pfizer has announced that it is seeking emergency use authorization for its new COVID-19 oral antiviral candidate PAXLOVID™ designed to treat mild to moderate COVID-19 symptoms in at-risk individuals

If approved by the FDA, PAXLOVID™ will be the first oral antiviral of its kind. Prescribed as an at-home treatment for at-risk patients at the first sign of infection, the 3CL protease inhibitor is designed to combat SARS-CoV-2 (Coronavirus) and will potentially help patients avoid serious illness and hospitalisation

Could this mark a monumental change in the battle against COVID-19, Pfizer’s Chairman and Chief Executive officer, Albert Bourla stated that “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.”

Success so far?

After positive results in the EPIC-HR interim analysis, Pfizer is looking for emergency use authorised (EUA) for its new COVID-19 pill.

The interim analysis enrolled non-hospitalised adults aged 18 and over who both had a confirmed COVID-19 status and were at an increased risk of progressing to severe illness.

According to the report “the data demonstrated an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients treated with PAXLOVID™ compared to a placebo.”

“89% reduction in risk of Covid-19-related hospitalisation or death from any cause”

Cost around the globe

Pfizer has announced that it is committed to ensuring ‘equitable access to PAXLOVID for all people’ and that if authorised or approved, ‘during the pandemic, Pfizer will offer our investigational oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe.’

The Billion dollar company has also chosen to invest up to $1 billion of its own funds to support the manufacturing and distribution of this new candidate, in order to help aid in the global effect to control the COVID-19 pandemic.


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