As the drug approval process becomes ever more complicated, the FDA is stepping up efforts to speed up new medication launches. The agency plans to use artificial intelligence to “radically increase efficiency” in deciding whether to approve drugs and devices. The move is among several top priorities laid out in an article published Tuesday in JAMA. Other initiatives include a review of chemicals and other “concerning ingredients” that appear in U.S. foods but not in the food of other developed nations, as well as a push to cut the final stages of making a drug or device approval decision down to weeks.
The year’s first preview of 2025 drug approvals comes with a healthy dose of caution over sales estimates, as translating research into a successful regulatory application has proven incredibly challenging in recent years. That’s reflected in Evaluate’s sales estimate of Alzheimer’s hopeful donanemab, which has seen its initial forecasts continually revised downwards over the past two years.
Vaccines, Cures for Hematology, and More
The FDA delivered a number of milestones in 2018, including the first drug to treat smallpox, SIGA Technologies’ Tpoxx (tecovirimat); the first treatment to treat an inherited form of rickets known as x-linked hypophosphatemia, Ultragenyx Pharmaceuticals’ Crysvita (burosumab-twza); and the first cannabidiol-based drug, GW Pharmaceuticals’ Epidiolex (cannabidiol).
Also in 2018, the FDA approved a combination of three medications to improve the outcomes of multiple myeloma patients who do not qualify for a stem cell transplant. The combination of daratumumab, lenalidomide, and dexamethasone is called VRd therapy and is a continuation of researchers’ attempts to find more effective treatments for people who cannot get a stem cell transplant.