2024 drug approvals, breakthroughs, and trends
The Food and Drug Administration (FDA) approved 50 novel drugs in 2024, 5 less than the amount approved in 2023. March and December were the busiest months for approvals, with 7 drugs each, while January and May were the slowest, with just 1 approval each.
Key therapeutic areas
Cancer treatments dominated the list of approvals with 13 new drugs targeting various forms of the disease. Four of these were specifically for lung cancer, the leading cause of cancer-related deaths in the U.S. Other cancers addressed included biliary tract, bladder, brain, breast, esophageal, gastric, leukemia, and skin cancers.
In addition to cancer therapies:
- Mental health: A single new drug was approved for schizophrenia.
- Blood-related illnesses: Seven new treatments were approved, including those for hemophilia.
- Skin diseases: Three new drugs were introduced.
- Liver-related diseases: Three novel treatments were approved.
- Rare conditions: New medicines were approved for Niemann-Pick disease Type C, familial chylomicronemia syndrome, and WHIM syndrome.
2025 outlook
Several drugs are in the spotlight for potential approval this year:
- Suzetrigine: A non-opioid pain medication anticipated for early approval in 2025. However, it faced setbacks in late 2024, as clinical trials showed no significant benefit over a placebo for sciatica patients.
- Rexulti® (brexpiprazole): Originally approved in 2015 for major depressive disorder, schizophrenia, and agitation associated with Alzheimer’s disease, Rexulti may gain approval to treat post-traumatic stress disorder (PTSD) in combination with sertraline.
- GLP-1 receptor agonists: Expanding beyond diabetes and obesity, these drugs are being investigated for additional uses. For example:
- Zepbound®: Approved in December 2024 for obstructive sleep apnea in adults with obesity, marking the first treatment for this condition.
- Ozempic®: While approved in 2017 for type 2 diabetes, ongoing studies suggest it may be effective in treating chronic kidney disease.
With these developments, 2025 holds promise for further advancements in treatments across a wide range of conditions.
Further reading
- A look forward: Five trends PBMs should expect in 2025
- A look back: Top 5 PBM 2024 market trends
- Insights Hub
- GLP-1 Trends
- One size does not fit all: GLP-1 weight loss coverage options for three companies
References
- Novel Drug Approvals for 2024. FDA.gov: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024
- Dennis, Matthew. Vertex’s non-opioid pain drug no better than placebo in sciatica study. FirstWord Pharma. December 19, 2024: https://firstwordpharma.com/story/5922661
- Gerlach, Alexandra. FDA Accepts sNDA for Brexpiprazole for Adult Patients With PTSD. Pharmacy Times. June 25, 2024: https://www.pharmacytimes.com/view/fda-accepts-snda-for-brexpiprazole-for-adult-patients-with-ptsd
- Zepbound approved by FDA as first sleep apnea medication. American Academy of Sleep Medicine. December 21, 2024: https://aasm.org/zepbound-approved-fda-first-sleep-apnea-medication/
- Miller, Korin. What You Need to Know About Ozempic and Chronic Kidney Disease. Prevention. July 26, 2024: https://www.prevention.com/health/health-conditions/a61691274/ozempic-chronic-kidney-disease/
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