Pfizer PFE announced that the FDA granted full approval to its oral COVID-19 treatment Paxlovid (nirmatrelvir tablets and ritonavir tablets) for use in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Following the grant of full approval, Paxlovid is the first approved oral antiviral treatment for COVID-19 in the United States. The drug was initially grantedemergency use authorization (“EUA”) by the FDA in 2021 for a similar indication.
The FDA’s decision is primarily based on data from the phase II/III EPIC-HR study, which evaluated Paxlovid in unvaccinated, non-hospitalized adults aged 18 years and older. Patients who were administered Paxlovid within five days of symptom onset showed 86% reduction in risk of COVID-19-related hospitalization or death.
Pfizer also confirmed that Paxlovid’s distribution will continue to be overseen by the U.S. government, with certain country residents eligible to receive the medicine at no charge.
Shares of Pfizer have lost 26.2% in the year so far against the industry’s 0.4% growth.
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Paxlovid will continue to remain available under EUA to treat pediatric patients (aged 12-17 years) and weighing at least 40 kg with COVID-19. Pfizer is currently conducting the ongoing phase II/III EPIC-Peds study to gather pediatric data on the drug and intends to file a supplemental new drug application (“sNDA”), with the FDA seeking full approval for use of Paxlovid in the 12–17-year age group.
Other than Pfizer, Merck MRK also developed its own oral antiviral for COVID-19, molnupiravir. The Merck antiviral, which is marketed under the brand name Lagevrio, received EUA from the FDA in December 2021 for treating mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19 and for whom alternative COVID-19 treatment options are not clinically appropriate. During first-quarter 2023, Merck recorded $392 million from Lagevrio sales.
Though Paxlovid is the first FDA-approved oral antiviral for COVID-19, it is the fourth drug to receive full approval for use in COVID-19 infection. The other approved COVID therapies are intravenous or injectable drugs administered at a clinic or hospital.
One such therapy is Veklury (remdesivir), marketed by Gilead Sciences GILD, which has been approved in the United States since 2020. Gilead’s Veklury is approved by the FDA to treat moderate-to-severe COVID-19 in adults and pediatric patients who are at high risk of progression to severe COVID-19.
Currently, COVID-19 related medicines are facing a significant decline in sales on account of reduced hospitalizations and majority of the population immunized with authorized COVID vaccines. Earlier this month, the United States government also ended the public health emergency status for COVID-19.
Pfizer Inc. Price
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Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Allogene Therapeutics ALLO, which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Allogene Therapeutics’ 2023 loss per share have improved from $2.44 to $2.31. During the same period, the loss estimates per share for 2024 have narrowed from $2.46 to $2.21. Shares of Allogene Therapeutics have declined 13.0% in the year-to-date period.
Earnings of Allogene Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 5.08%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 7.94%.
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