August 2022: Notable Drug Approvals


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Hematological Disorders
Zynteglo (betibeglogene autotemcel) Hematopoietic stem cell gene therapy Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. Zynteglo Approved as First Gene Therapy for Beta-Thalassemia
Metabolic Disorders
Xenpozyme (Olipudase alfa-rpcp) Hydrolytic lysosomal sphingomyelin-specific enzyme replacement therapy Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients. Xenpozyme Approved for Acid Sphingomyelinase Deficiency
Neurologic Disorders
Zonisade (zonisamide oral suspension) Carbonic anhydrase inhibitor Adjunctive therapy for the treatment of partial-onset seizures in patients 16 years of age and older. Oral Suspension Formulation of Zonisamide Gets FDA Approval
Enhertu (fam-trastuzumab deruxten-nxki) HER2-directed antibody + topoisomerase inhibitor conjugate Treatment of adults with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 mutations and who have received a prior systemic therapy. Enhertu Drug Monograph
Nubeqa (darolutamide) Androgen receptor inhibitor Treatment of adults with metastatic hormone-sensitive prostate cancer. Nubeqa Drug Monograph
Pemazyre (pemigatinib) Fibroblast growth factor receptor inhibitor Treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement. Pemazyre Drug Monograph
Ophthalmic Disorders
Cimerli (ranibizumab-eqrn) Vascular endothelial growth factor inhibitor Treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. Cimerli Approved as Interchangeable Biosimilar to Lucentis
Psychiatric Disorders
Auvelity (dextromethorphan HBr-bupropion HCI) Noncompetitive N-methyl-D-aspartate receptor antagonist and a norepinephrine and dopamine reuptake inhibitor Treatment of adults with major depressive disorder. Auvelity Approved for Major Depressive Disorder
Urological Disorders
Kyzatrex (testosterone undecanoate) Testosterone undecanoate Testosterone replacement therapy in adult males for conditions associated with deficiency or absence of endogenous testosterone. FDA Approves Oral Testosterone Replacement Therapy Kyzatrex