It was far from a banner year for FDA approvals in 2022 as the agency ended a five-year streak of green lighting at least 46 novel molecular entities (NMEs) annually.
The agency approved just 37 novel drugs in 2022, compared to 50 in 2021 and 53 in 2020. In fact, the number of NME approvals were the lowest they’ve been since 2016, a year that saw only 22 drugs pass muster at the agency.
While the FDA did not disclose a specific reason for the drop in approvals, the agency was a frequent target of criticism in 2022 for potentially moving too fast on some drugs — especially those in the accelerated approval process. It has also drawn ire for 2021’s contentious Alzheimer’s approval that led to the resignation of three panelists from an independent review board.
Despite the lower NME approval numbers, the agency highlighted its achievements in rare disease, first-in-class approvals, and revamped pathways for enhanced and expedited drug review.
For instance, the FDA’s Center for Drug Evaluation and Research (CDER) approved 28 of the 37 novel drugs of 2022 (76%) on the “first cycle” of review. Still, that’s down from 2021, when its first cycle approval rate was 86%.
Many of the approvals were in the oncology space, including Bristol Myers Squibb’s combination therapy Opdualag for advanced melanoma, which showed evidence of equal efficacy and fewer side effects than the current standard of care, the National Cancer Institute reported.
It also granted fast track status to 12 of the 37 novel drugs approved in 2022, including approving six that made use of the accelerated approval process.
Besides having lower numbers of NME approvals, 2016 and 2022 had something else in common: During both years the FDA was helmed by Commissioner Robert Califf, who returned to the role in February after serving under Barack Obama from February 2016 to January 2017.
Upon taking office, Califf tweeted that his priorities for the FDA included “building on efforts to help speed development of new treatments & medical devices, across the medical landscape.”
He’s also spoken about the importance of streamlining — and thus speeding — the drug approval process and discussed the importance of “fast failure” to more quickly cull drugs that won’t succeed from the development pipelines at the Drug Information Association’s annual meeting in June, PharmaVoice reported.
“Both successes and failures can be critical to guiding developers to the best and most efficient pathway, and help them save time and money, prevent wasted or duplicative efforts, and ensure speedy development of the best and most effective products,” he said at the meeting.
While falling short on novel drug approvals, the FDA made progress in the generic and biosimilar department. In addition to the 37 novel drugs in 2022, the FDA also logged 99 first-time generic approvals, which was more than the prior two years, and seven new biosimilar products, including two interchangeable biosimilars. The agency also marked its 40th biosimilar approval in 2022 as the U.S. catches up to European approvals of the copycat biologics aimed at increasing competition in the market.
FDA NME approvals in 2022 — by the numbers:
20
were first-in-class.
20
were approved to treat orphan diseases.
25
were approved in the U.S. before any other country.
24 of the 37 novel drug approvals of 2022 used one or more expedited approval programs
12
were granted fast track status.
21
were designated as priority review.
6
received accelerated approval.
13
were designated as breakthrough therapies.
It was a good year for generics and biosimilars
99
first-time generics were approved.
7
biosimilars were approved.
2
interchangeable biosimilars received approval.
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