Pfizer, Inc.'s PFE oral COVID-19 antiviral treatment Paxlovid was ratified by another health regulator ahead of the dawn of the new year.
What Happened: The U.K.'s Medicines and Healthcare Products Regulatory Agency announced Friday it has approved Pfizer's Paxlovid for treating COVID-19 infection.
Since Paxlovid is most effective when taken during the early stages of infection, the MHRA said it is recommending its use as soon as possible and within five days of the start of symptoms. It has been authorized for use in people ages 18 and above who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age, diabetes and heart disease.
"We now have a further antiviral medicine for the treatment of COVID-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before COVID-19 has progressed to a severe stage," said Dr. June Raine, MHRA, chief executive.
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Why It's Important: Paxlovid has been authorized by the U.S. Food and Drug Administration. It has also been endorsed by the European Medicines Agency's Committee for Medicinal Products for Human Use but is yet to receive conditional approval.
Paxlovid is a combination of PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication. The two active substances of Paxlovid come as separate tablets that are packaged and taken together orally, twice a day for five days.
Pfizer has reached agreements with the U.K. government to supply 2.75 million treatment courses of Paxlovid through 2022.
The antiviral combo will likely fetch for Pfizer revenues of $95 million in 2021, $24 billion in 2022 and $33 billion in 2023, according to SVB Leerink analyst Geoffrey Porges.
In premarket trading, Pfizer shares were up 0.33% at $58.59.
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Photo courtesy of Pfizer.
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