Pfizer Submits FDA Application for Emergency Approval of COVID Treatment Pill

• The pill, if authorized by the FDA, could help revolutionize the fight against COVID by allowing high-risk people infected with the virus to take an oral anti-viral drug at home.
• Such a treatment could help reduce the strain that has been put on hospital systems during the pandemic.
• In a clinical trial of people 18 and over at an increased risk of developing severe COVID, the pill reduced hospitalization and death by 89% when taken within three days of the onset of symptoms

Pfizer on Tuesday submitted its application to the Food and Drug Administration for emergency authorization of its COVID-19 treatment pill, saying it reduces hospitalization and death by 89% when administered with a common HIV drug.

The pill, if authorized by the FDA, could help revolutionize the fight against COVID by allowing high-risk people infected with the virus to take an oral anti-viral drug at home instead of going to the hospital. Such a treatment could help reduce the strain that has been put on hospital systems during the pandemic.

In a clinical trial of people 18 and over at an increased risk of developing severe COVID, the pill reduced hospitalization and death by 89% when taken within three days of the onset of symptoms, according to Pfizer.

The pill, known as Paxlovid, blocks the activity of an enzyme the virus needs to replicate. Paxlovid is used in combination with a low-dose of ritonavir, an HIV drug, to slow the patient's metabolism, allowing the drug to remain active in the body at a higher concentration for a longer period to combat the virus.

Pfizer said the COVID treatment proved to be safe, adding that there were fewer adverse events reported by trial participants who took Paxlovid than the placebo, and most of those were "mild in intensity."

If approved, Paxlovid will be administered in two 150 mg tablets along with one 100 mg tablet of ritonavir twice daily.

"We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world," Pfizer CEO Albert Bourla said in a statement Tuesday.

Bourla had previously said that Pfizer planned to submit its data to the FDA before Thanksgiving.

The Biden administration is expected to announce a multibillion-dollar deal this week to purchase 10 million courses of Pfizer's pill, according to The Washington Post.

Earlier Tuesday, Pfizer announced that it will allow generic drug manufacturers to produce the pill through a licensing agreement with the Medicines Patent Pool, a U.N.-backed public health group. Those manufacturers will supply the generic pill to 95 middle and low-income countries. Pfizer will wave royalty fees for low-income countries, as well as other nations covered by the agreement as long as the World Health Organization classifies COVID as a public health emergency of international concern.

Merck is also developing an antiviral pill, Molnupiravir, to combat COVID. The company found in an interim analysis that the pill reduced the risk of hospitalization and death by 50% in adults with mild to moderate COVID. 

Merck, which developed the drug with Ridgeback Biotherapeutics, submitted its application to the FDA last month for the pill to receive emergency authorization.