March 2023: Notable Drug Approvals


Pharmacologic Class


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Neurologic Disorders
Daybue (trofinetide) Synthetic analogue of glycine-proline-glutamate Treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. FDA Greenlights Daybue for Treatment of Rett Syndrome
Verzenio (abemaciclib) Kinase inhibitor In combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence. Verzenio Drug Monograph
Tafinlar (dabrafenib) + Mekinist (trametinib) Kinase inhibitors Treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. Tafinlar + Mekinist Approved for Pediatric BRAF V600E Low-Grade Glioma
Zynyz (retifanlimab-dlwr) Programmed death receptor-1-blocking antibody Treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. Zynyz Approved for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
Pain Management
Zavzpret (zavegepant) Calcitonin gene-related peptide receptor antagonist Treatment of migraine with or without aura in adults. Zavzpret Nasal Spray Approved for Acute Treatment of Migraine
Immune Disorders
Joenja (leniolisib)  Selective PI3Kδ inhibitor Treatment of activated phosphoinositide 3-kinase delta syndrome in patients 12 years of age and older. Joenja Approved for Activated Phosphoinositide 3-Kinase Delta Syndrome
Infectious Disease
Rezzayo (rezafungin for injection) Echinocandin antifungal Treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. FDA Approves Antifungal Rezzayo for Patients With Limited Treatment Options