The FDA approved 50 novel drugs in 2024, a slight decrease from 55 the previous year. The approvals included new molecular entities and biologics only. Prime’s Serve You Rx team analyzes these drug approvals to help clients optimize benefit strategies and drive cost savings in the pharmacy.
A significant portion of the new approvals (16 drugs) were for oncology innovations including first-in-class treatments and new approaches to existing therapies. A number of breakthrough innovative therapies also received accelerated development and approval, with some receiving Orphan Drug designation targeting diseases affecting fewer than 200,000 Americans (e.g., atypical antipsychotic cobenfy from Karuna Therapeutics and ultragen’s UX111 for Sanfilippo syndrome type A).
Prime’s analysis identifies 18 notable drugs positioned for potential FDA approval in 2025 including a new GLP-1 formulation from Novo Nordisk, oral semaglutide (Wegovy), and etuvetidigene autotemcel from Ultragenyx for Wiskott-Aldrich syndrome, an X-linked genetic disease with immune deficiency and low platelet counts. Other promising new drugs include gepotidacin, an FIC DNA topoisomerase 2 inhibitor from Merck & Co., and elinzanetant, a dual antagonist targeting both neurokinin 1 and 2 receptors from Disc Medicine.
Another interesting development is the FDA’s recent pilot program and lean into artificial intelligence (AI). The agency has begun leveraging AI in the drug approval process with its first-in-class Elsa generative AI tool to streamline and accelerate reviews. This is one of many efforts to modernize the FDA and increase efficiency, which may result in accelerated drug review timelines.