Each year, the US Food & Drug Administration’s Centre for Drug Evaluation and Research (CDER) approves a wide range of new drugs and biological products.
The listing of new molecular entities and new therapeutic biological products that CDER approved in 2023 – which does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Centre for Biologics Evaluation and Research approved last year – includes some that are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
On the list are cancer drugs – Fruzaqla (fruquintinib), to treat refractory, metastatic colorectal cancer, and Augtyro (repotrectinib) for ROS1-positive non-small cell lung cancer, as well as Epkinly (epcoritamab-bysp), to treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy.
Also approved were Truqap (capivasertib) to treat breast cancer that meets certain disease criteria, and Ogsiveo (nirogacestat), to treat adults with progressing desmoid tumours who require systemic treatment.
To treat wounds associated with dystrophic and junctional epidermolysis bullosa, the FDA approved Filsuvez (birch triterpenes), while to reduce catheter-related bloodstream infections in adults with kidney failure receiving chronic haemodialysis through a central venous catheter, approval was granted for Defencath (taurolidine, heparin).
Agamree (vamorolone) made the list for the treatment of Duchenne muscular dystrophy, while to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the FDA approved Bimzelx (bimekizumab).
For the treatment of postpartum depression, Zurzuvae (zuranolone) was approved, while Exxua (gepirone) was approved for major depressive disorder.
Among the dozens of other drugs approved were one for heart failure (Inpefa), for severely patchy hair loss (Litfulo), dry eye disease (Miebo) and to reduce menopausal hot flushes, Veozah.
FDA article – Novel Drug Approvals for 2023 (Open access)
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