Health system pharmacists and physicians are monitoring a wave of expected new drug approvals between late 2024 and third quarter of 2025.
A recent article published in the American Journal of Health-System Pharmacy outlines several therapies likely to have a clinical and financial impact on hospitals and clinics.
Here are some of the most anticipated drugs to watch:
- Suzetrigine for acute pain: By the end of the first quarter of 2025, Vertex’s oral, nonopioid pain medication could be approved for moderate-to-severe acute pain. In two phase 3 trials, it showed relief within 48 hours, though it did not outperform hydrocodone and acetaminophen on secondary endpoints.
- Remestemcel-L for pediatric graft versus host disease: Expected in the first quarter of 2025, the intravenous cell therapy from Novartis and Mesoblast may become the first approved treatment for steroid refractory acute graft-versus-host disease in children under 12. In clinical trials, the therapy improved survival outcomes based on day-28 response rates.
- Bentracimab to reverse anticoagulation: SERB Pharmaceuticals’ monoclonal antibody fragment targets the reversal of ticagrelor’s blood thinning effects. Phase 3 trial data showed rapid reversal and an FDA decision is expected in early 2025.
- Mirdametinib for neurofibromatosis Type 1: Pfizer and SpringWorks Therapeutics are seeking approval for an oral MEK inhibitor in the first quarter of 2025. It is intended for adults with NF1-associated plexiform neurofibromas.
- Nipoclimab for myasthenia gravis: By the second quarter of 2025, Johnson & Johnson’s IV therapy may be approved for generalized myasthenia gravis. The therapy works by blocking the neonatal Fc receptor, reducing circulating immunoglobulin in blood. In the latest study, it improved patient-reported daily function.
- Sebetralstat for hereditary angioedema: KalVista Pharmaceuticals’ oral therapy could become the first FDA-approved oral treatment for hereditary angioedema by mid-2025. Current options are limited to injections or infusions.
- Revumenib for acute leukemia: Syndax’s menin inhibitor is under FDA review for patients with KMT2A rearrangements or NMP1 mutations. If approved in late 2024 or early 2025, it would offer a targeted approach for relapsed or refractory leukemia.
- Zanidatamab for biliary tract cancer: Jazz Pharmaceuticals is seeking approval for this HER2-targeted IV therapy. It could expand treatment options for cancer with a few effective therapies.
- Concizumab for hemophilia: Novo Nordisk’s anti-tissue factor pathway inhibitor therapy is under review for prophylactic use in hemophilia A or B with inhibitors. Clinical trial data showed reduced annualized bleeding rates.
- Revakinagine taroretcel for macular telangiestasia: Neurotech’s implant-based gene therapy may become the first FDA-approved treatment for this rare retinal condition. It delivers a protein to slow vision loss and is currently under review for approval.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
