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FDA Emergency Authorization Seeking for Experimental Covid-19 Pill by Pfizer

Pfizer stated on Tuesday that it has applied to the US Food and Drug Administration (FDA) for an emergency use authorization for its experimental antiviral Covid-19 tablet, also known as PF-07321332 or Paxlovid. There is an urgent need for life-saving treatment alternatives since this deadly disease has claimed the lives of almost 5 million people worldwide.

The high efficacy of PAXLOVID in a recent clinical trial and its potential to save lives and keep people out of the hospital if approved highlight the vital role that oral antiviral treatments could play in the fight against COVID-19.According to the company, the pill will be used in conjunction with an earlier antiviral medicine called ritonavir to treat mild to moderate Covid-19 in patients who are at a higher risk of hospitalization or death.

Pfizer released topline results from the experiment earlier this month, stating that an interim analysis conducted before the trial’s scheduled finish revealed an 89 percent reduction in the risk of hospitalization or death among those who received Covid-19 during the first three days of symptom start.Pfizer claims that it will invest up to $1 billion in developing and distributing this medicine. It has rolling submissions for the pill in nations like the United Kingdom, Australia, New Zealand, and South Korea.

Merck and Ridgeback Biotherapeutics have also applied to the FDA for emergency use permission of molnupiravir, an antiviral tablet; an FDA advisory group will meet on November 30 to review the application. Molnupiravir, the first oral antiviral to be approved for the treatment of Covid-19, received approval from the UK Medicines and Healthcare Products Regulatory Agency earlier this month.

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