Pfizer Inc.’s Covid-19 treatment Paxlovid gained key backing from US advisers for full approval, paving the way for the drug to become a source of revenue well into the future after it was cleared for emergency pandemic use.
(Bloomberg) — Pfizer Inc.’s Covid-19 treatment Paxlovid gained key backing from US advisers for full approval, paving the way for the drug to become a source of revenue well into the future after it was cleared for emergency pandemic use.
A Food and Drug Administration advisory committee voted 16-1 Thursday favoring full agency clearance for Pfizer’s antiviral to treat mild-to-moderate Covid-19 in adults at risk of developing severe illness. Panelists pointed to high efficacy and sound safety data in their almost unanimous decision, while some said that proper labeling to note the risk of drug interactions will be crucial. The recommendations of the Antimicrobial Drugs Advisory Committee aren’t binding, but the agency usually follows them.
The Biden administration is set to end the pandemic emergency on May 11, three years after it was first declared in response to the worldwide outbreak of SARS-CoV-2. While easing deaths and hospitalizations have diminished use of Covid treatments and vaccines, approval would allow the drugmaker to expand marketing efforts that might boost non-government purchases.
Pandemic authorizations for Covid vaccines, treatments and other products are independent of the emergency declaration and will remain in effect after May 11, according to the FDA, and new authorizations may be issued. Although earlier studies had indicated that the drug prevented some 90% of severe cases, some more recent studies in different populations have shown a more muted effect.
“While the benefit isn’t at the 90% relative-risk reduction, even at the 50% demonstrated by EPIC-SR, it’s demonstrating continued benefit in terms of the most severe outcomes and death,” said David Hardy, an infectious disease specialist from the University of Southern California Keck School of Medicine who sits on the committee.
Drugs like Paxlovid are critical for preventing Covid hospitalizations and deaths, Pfizer said in a statement following the panel’s vote.
Pfizer has yet to say how much it would charge for Paxlovid on the commercial market. It expects the pill to draw $8 billion globally this year, down 58% from 2022 and less than Wall Street analysts had originally forecast. The company has come under pressure to show other avenues of growth amid the downturn in its Covid business and recently announced a $43 billion takeover of cancer-drug maker Seagen Inc. that will help set a course out of the pandemic.
Pfizer shares were little changed as of 3:28 p.m. in New York.
Future Studies
Pfizer estimates there are more than 100 million Americans at risk for severe Covid-19. Paxlovid could prevent 13,000 hospitalizations and save 1,500 lives in the US each week, the FDA staff said in documents released before the meeting, noting that some patients suffered serious reactions due to interactions with other medications. About one-quarter of otherwise Paxlovid-eligible patients are unable to take the drug because of such reactions.
Currently, the only fully FDA-approved Covid drug for non-hospitalized patients who are at high risk of progression to severe disease is Gilead Sciences Inc.’s remdesivir, also called Veklury, administered intravenously. Doctors can also give Merck & Co.’s antiviral molnupiravir, which the National Institutes of Health says should only be used when other drugs can’t be given.
Future studies will be needed to show how much of an effect the drug has as more of those treated have some pre-existing immunity to the virus, either from vaccines or earlier infections, Lindsey Baden, a Harvard Medical School infectious disease specialist who chaired the panel, said.
“The strength of the data in those with pre-existing immunity are much thinner,” he said. “And it’s something we will have to pay attention to.”
–With assistance from Riley Griffin, Fiona Rutherford and Ilena Peng.
(Updates with panel comments from second paragraph.)
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