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.
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