In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore?
In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals.
With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023.
Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster.
Two of the newly approved Pfizer treatments were acquired with the help of the firepower the company gained with its massive sales of COVID vaccine Comirnaty and antiviral Paxlovid. Pfizer’s new ulcerative colitis drug Velsipity came by way of the company’s 2022 acquisition of Arena Pharmaceuticals for $6.7 billion. New nasal spray migraine therapy Zavzpret arrived by way of Pfizer’s $11.6 billion buyout of Biohaven, which also brought soon-to-be blockbuster migraine drug Nurtec.
The new Pfizer products cover a wide swath of indications between multiple myeloma drug Elrexfio, OPKO-partnered growth failure treatment Ngenla, first-in-class alopecia therapy Litfulo, RSV vaccine Abryvso and COVID-19 antiviral Paxlovid, which gained a full approval.
Pfizer has never scored in one year with so many diverse products. In 2018, for example, when the company achieved four approvals, all of the blessings were for oncology drugs.
Martin Mackay, Ph.D., now the co-founder of Massachusetts biotech RallyBio who formerly guided the R&D efforts at Pfizer, remembers being ridiculed in 2010 when he told Bloomberg Television that the company—which was in a minor lull at the time—and the industry in general were in a “golden age of drug discovery.”
These days, Mackay is getting the last laugh.
“I was watching what was coming through the pipeline,” Mackay said in a recent interview with Fierce Pharma. “I was watching all the new modalities that were at our fingertips—cell therapy, gene therapy, RNA, interference RNA, messenger RNA, neucleotides, gene editing—my thought then was that 10 years from now it’s gonna be terrific in terms of approvals.”
Bounty of approvals in 2023
After 2022 produced just 37 new drug approvals—the fewest by the FDA since 2016—the United States regulator signed off on a bumper crop of 55 new drugs in 2023. The list was the second longest in FDA history, coming up just shy of the single-year record of 59 approvals, which was set in 2018. Since this annual report includes vaccine and biologics approvals, the total haul came to 66 new drugs and biologics.
Mackay expects the annual numbers to continue to grow over the next decade. Looking at a list of approvals from a decade or two ago, Mackay said he was struck by the wide variety of modalities on this year's list.
"And interestingly, small molecules are still the most," Mackay said. "That doesn't surprise me either because they're proven agents. They haven't stayed the same. The technology to work on small molecules is just so different from when I started in the industry."
One potential explanation for the difference between the amount of approvals between 2022 and 2023 were the COVID-related inspection delays which held up some approvals. Another potential reason for the dearth of FDA approvals in 2022 could have been the heat the agency took for its much-criticized 2021 nod for Biogen and Eisai’s Alzheimer’s disease drug Aduhelm.
Cancer, as usual, saw the most approvals in 2023 with 16, including four bispecifics in a span of as many months. Two bispecifics for multiple myeloma—Talvey from Johnson & Johnson and Elrexfio from Pfizer—made the grade. There also were two bispecifics approved for B-cell lymphomas—Columvi from Roche and Epkinly from AbbVie and Genmab. Talvey and Epkinly have been tabbed with blockbuster potential.
Gene Therapies
Two of the most significant green lights came on the same day, Dec. 8, and for the same indication, sickle cell disease. Vertex and CRISPR landed a historic thumbs up for Casgevy, which became the first drug to reach the market developed with the revolutionary CRISPR gene editing technology. Simultaneously, bluebird bio earned its nod for another gene therapy, Lyfgenia.
Bluebird priced its treatment at $3.1 million, compared to $2.2 million for Casgevy, raising eyebrows at the time. But good news came days after the approval from bluebird as it signed a reimbursement deal with a major insurer.
Two other pricey gene therapies made the grade, as well. The single-dose tab for BioMarin’s Roctavian, which treats hemophilia A, clocks in at $2.9 million. Sarepta broke through with a ballyhooed approval to treat Duchenne muscular dystrophy with Elevidys and priced it to match the hype at $3.2 million.
RSV Vaccines Make the Grade
Also making major news in 2023 was the long-awaited emergence of RSV vaccines. GSK scored first in May with Arexvy for people 60 and older, followed by Pfizer which gained two nods for Abrysvo. In July, Sanofi and AstraZeneca gained a blessing for their antibody, Beyfortus, to protect infants. By 2028, each of the products is expected to generate sales of between $1.3 and $1.7 billion.
The first year of rolling out the RSV antibody didn’t go smoothly, however. In late 2023, amid a shortage of Beyfortus, Sanofi and AZ were scrambling to ramp up manufacturing. The companies were taken to task by U.S. lawmakers, demanding answers for their inadequate preparations.
Other Key Approvals
In the closely watched Alzheimer’s disease space, Biogen and Eisai won a nod for their treatment Leqembi. The blessing came 19 months after the FDA rejected an advisory committee recommendation and signed off on Biogen’s ill-fated Aduhelm.
The FDA blessing of Leqembi even came by way of the same accelerated pathway that facilitated Aduhelm’s highly criticized green light. But there are several reasons to be optimistic about the launch of Leqembi as it posted superior trial results and—in contrast to Aduhelm—its nod was recommended unanimously by a panel of independent advisors, paving the way for a full approval.
On the flip side, the FDA rejected Eli Lilly’s touted Alzheimer’s treatment donanemab. But the company appears to be on track for approval in 2024.
Other big winners in ’23
Four companies—GSK, Biogen, Chiesi and UCB—secured three approvals each in 2023. The trio for UCB included two nods which came on the same day in October, for plaque psoriasis medicine Bimzelx and myasthenia gravis treatment Zilbrysq. The Belgium-based company also earned a green light for another myasthenia gravis drug with a different mechanism of action, Rystiggo.
Biogen’s winners were Qalsody in ALS and two partnered drugs—Alzheimer’s med Leqembi, which it shares with Eisai, and postpartum depression drug Zurzuvae, which it splits with Sage.
GSK scored for myelofibrosis drug Ojjaara, kidney disease treatment Jesduvroq and RSV vaccine Arexvy. Chiesi of Italy gained approval for Fulsuvez for a rare skin condition and two enzyme replacement therapies—Lamzede and Elfabrio.
Another company that excelled with two major approvals was Astellas. The Japanese company scored with Veozah, a breakthrough treatment for hot flashes and night sweats. It also won approval for Izervay, a treatment for geographic atrophy that it acquired in its $5.9 billion buyout of Iveric Bio in early 2023. Both Veozah and Izervay have been pegged to exceed peak sales of more than $2 billion as the company attempts to compensate for the looming patent cliff for prostate cancer drug Xtandi.

https://www.fiercepharma.com/special-reports/2023-drug-approvals-after-down-year-fda-signs-bounty-new-medicines