Biopharma breakthrough year: FDA approved 50% more novel drugs in 2023
The Food and Drug Administration approved 55 new treatments in 2023, representing a nearly 50% increase from the year before, with Pfizer gaining the highest number of high-profile approvals covering a wide range of illnesses.
Biotech pharmaceutical companies may be poised for a big year in 2024. The U.S. Food and Drug Administration approved nearly 50% more novel drugs last year than in 2022, raising optimism among industry analysts and investors.
Approvals for products containing an active ingredient or molecule not previously approved rose to 55 in 2023, up from 37 in 2022 and 51 in 2021. The FDA typically approves from 45 to 50 new drugs annually, with a high of 59 in 2018. High-profile approvals in 2023 included:
- Eli Lilly’s obesity drugs Zepbound and Eisai
- Biogen’s Alzheimer’s treatment Leqembi
- 5 gene therapies, including a sickle cell disease treatment from Vertex Pharmaceuticals and CRISPR Therapeutics.
“It is good to see the FDA approvals go up,” said John Stanford, executive director of Incubate, a group of life sciences investors. “Our scientists can do a lot more, and from that perspective we are excited about what’s coming down the pipeline, not just in 2024, but beyond that.”
Cancer treatments, as usual, saw the most approvals in 2023 with 16, including four bispecifics. Two bispecifics for multiple myeloma –Talvey from Johnson & Johnson and Elrexfio from Pfizer – were approved. Two bispecifics also were approved for B-cell lymphomas, Columvi from Roche and Epkinly from AbbVie and Genmab.
Pfizer had seven FDA approvals in 2023, more than twice as many as any other company, continuing a three-year pattern. The new Pfizer products cover a wide variety of indications, including Elrexfio; growth failure treatment Ngenla, first-in-class alopecia therapy Litfulo; RSV vaccine Abryvso; and COVID-19 antiviral Paxlovid, which gained a full approval.
The FDA, without providing a specific reason for the drop in approvals in 2022, said
“the number of novel drugs approved varies from year to year and may be due to a variety of factors.” These include the complexity of new drugs in development and advances in scientific understanding of diseases and disease targets, it said. In addition, during the pandemic, the agency operated with a remote workforce, which caused disruption and issues such as delayed inspections that affected drug reviews.
Related: The 9 most influential FDA-approved drugs and vaccines of 2023
Ritu Baral, an analyst for TD Cowen, expects a similar level of FDA approvals in 2024. “We’re back at those peak levels, she said, “which hopefully means that the workflow disruptions, staffing and bandwidth issues and, most importantly, communications with developers, have been improving.”