Pfizer oral COVID-19 pill gets FDA authorization, first oral drug for at-home use

•  FDA’s authorized Paxlovid for patients of 12 years of age and older, weighing at least 88 pounds, with mild to moderate COVID-19 who are expected to be hospitalized or not survive

• Pfizer raised its production estimates to 120 million courses of treatment from 80 million in 2022

Pfizer Inc on Wednesday announced that the U.S. Food and Drug Administration (FDA) authorized its oral antiviral pill for COVID-19, making it the first at-home treatment for the coronavirus.

Pfizer’s clinical trial data showed its antiviral regimen has an efficacy rate of 89% in preventing hospitalizations and deaths among high-risk patients with severe illnesses.

Recent tests suggest that the drug retains its efficiency against omicron.

FDA cleared the oral pill for patients of 12 years of age and older, weighing at least 40 kilograms, or about 88 pounds, with mild to moderate COVID-19 who are expected to end up hospitalized or not survive.

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“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The agency said the drug will be available by prescription only and should be started as soon as possible after diagnosis and within five days of symptom onset.

Combat against omicron

Earlier, Pfizer CEO Albert Bourla told CNBC it had already delivered some pills in the U.S., which could be available to patients as early as this weekend.

The company has also raised its production estimates to 120 million courses of treatment from 80 million in 2022.

Moreover, Bourla said he expects the oral antiviral pill to be effective against the omicron variant of the virus.

If delivered in time, the pill could help lessen the impact of the omicron variant of the coronavirus on healthcare systems as the patients can take the regimen from their homes as the country is bracing for another wave of infections.

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“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,” Cavazzoni said.

Pfizer’s pills, Paxlovid, has to be taken in combination with the HIV drug ritonavir and are meant to be taken every 12 hours for five days.

Picture Credit: Reuters