Drug Approvals in 2023
<p>Oncology had the most approvals at 13, or about 24% of the total. This included several notable first-in-class therapies like AstraZeneca’s AKT inhibitor capivasertib for certain breast cancers, Springworks’ gamma-secretase inhibitor nirogacestat for desmoid tumors, and J&J’s GPRC5D-targeted antibody-drug conjugate talquetamab for multiple myeloma. T-cell engaging bispecific antibodies are gaining traction, with 4 new approvals in 2023. Neurology was second with 9 approvals. Alzheimer’s disease is a key focus, with Eisai/Biogen’s lecanemab receiving an accelerated approval based on amyloid plaque reduction, though its clinical benefit remains debated. Reata’s omaveloxolone for Friedrich’s ataxia was approved despite questionable efficacy data, reflecting the FDA’s flexibility with neurological disorders.</p>
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