FDA authorizes first at-home pill to treat COVID-19

WHAT YOU NEED TO KNOW:

• The US FDA on Wednesday approved the first Covid-19 antiviral pill to treat severe disease.
• Pfizer’s pill, Paxlovid, is the first at-home treatment for Covid-19 authorized for emergency use.
• Patients age 12 or older who are at a high risk of developing severe COVID-19 due to underlying medical conditions can use the oral drug.

The Food and Drug Administration approved the first pill designed to treat COVID-19 at home on Wednesday, as hospitals struggle with a flood of new patients and the highly contagious omicron variant spreads throughout the United States.

The pill, called Paxlovid, was created by Pfizer and is authorized for use in patients age 12 or older who are at a high risk of developing severe COVID-19 due to underlying medical conditions. Clinical trials showed that Paxlovid was 89% effective at keeping people with the virus from needing hospitalization if taken early in their illness.

“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” Pfizer CEO Albert Bourla said in a statement.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

Paxlovid is an anti-viral pill, and each pack contains 30 tablets taken over five days. For the full effect, patients need to start taking them within five days of the start of their symptoms.

The FDA’s authorization comes at a critical time in the U.S. — hospitals nationwide are overwhelmed with COVID-19 patients and the omicron variant is spreading rapidly. Paxlovid allows people to treat the virus at home and hopefully avoid the hospital.

Another anti-viral pill, created by Merck, is also expected to be authorized for use in the coming weeks.

The Biden administration has already purchased 10 million packs of Paxlovid, and Pfizer is currently working on producing enough to meet that request. They currently have tens of thousands of packs that are sitting in a warehouse in Memphis, awaiting the FDA’s authorization, but it is likely only enough for about 180,000 patients by the end of the year.

The U.S. is currently seeing some of the highest numbers of new COVID-19 infections of the entire pandemic. On Dec. 21, there were at least 188,798 new cases, and 69,537 people are currently hospitalized with COVID-19, according to The New York Times.

Source: People