BackUS FDA approves Pfizer's Covid antiviral pill Paxlovid for high-risk adults
Paxlovid is the fourth drug and and first oral antiviral pill approved by the FDA to treat COVID-19 in adults.
PremiumThe US Food and Drug Administration has granted full approval to Pfizer's oral antiviral COVID-19 treatment, Paxlovid, for adults are at high risk for progression to severe COVID-19, including hospitalisation or death.
Paxlovid is the fourth drug and and first oral antiviral pill approved by the FDA to treat COVID-19 in adults.
The approval for the pill, initially authorized in late 2021 for emergency use in the US, will provide doctors with more flexibility in prescribing it to adults with severe COVID-19 symptoms.
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"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19," FDA's Patrizia Cavazzoni said in a statement.
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The decision comes more than two months after a panel of advisers to the health regulator voted in favor of granting full approval for the drug.
As per the FDA's statement, the efficacy of Paxlovid was primarily supported by the final results of the EPIC-HR clinical trial.
Data presented by both the FDA and Pfizer during the advisory meeting helped ease safety concerns around a potential rebound in COVID-19 symptoms after a five-day Paxlovid course.
The concerns emerged after numerous anecdotal reports about a return of symptoms following treatment with Paxlovid, including in high-profile patients such as President Joe Biden and Dr. Anthony Fauci.
Earlier this month, Pfizer first-quarter profit and revenue outpaced analysts’ expectations as demand for its for pandemic products persisted even as they face pressure amid waning infections.
Adjusted first-quarter earnings were $1.23 a share, the company had said in a statement. Revenue of $18.3 billion also handily beat Wall Street expectation. The company left untouched its full year earnings guidance at $3.25 to $3.45 a share, and revenue at $67 billion to $71 billion.
The New York-based drugmaker announced the $43 billion planned acquisition of cancer-drug biotech Seagen Inc. earlier this year, giving investors more assurance that it’s seeking new avenues for growth.
Pfizer’s Covid vaccine Comirnaty and Paxlovid antiviral transformed the company, contributing more than half its $100 billion in sales last year. But in the first quarter, revenue for the shot fell 77 percent to $3.1 billion, more than the $2.6 billion analysts expected. Paxlovid saw quarterly purchases at $4.1 billion, beating estimates for $2.7 billion.
(With inputs from Reuters)
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