February 2023: Notable Drug Approvals


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Hematological Disorders
Altuviiio (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) Recombinant DNA-derived, Factor VIII concentrate Routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with hemophilia A.. Altuviiio Approved as Once-Weekly Factor VIII Therapy for Hemophilia A
Kidney Disease
Filspari (sparsentan) Endothelin and angiotensin II receptor antagonist To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. Filspari Granted Accelerated Approval to Reduce Proteinuria in IgA Nephropathy
Jesduvroq (daprodustat) Oral hypoxia-inducible factor prolyl hydroxylase inhibitor Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 4 months. Jesduvroq Approved for Anemia of CKD in Patients on Dialysis
Metabolic Disorders
Lamzede (velmanase alfa-tycv) Recombinant form of human lysosomal alpha-mannosidase Treatment of noncentral nervous system manifestations of alpha-mannosidosis. Lamzede Approved for Noncentral Nervous System Manifestations of Alpha-Mannosidosis
Musculoskeletal Disorder
Kevzara (sarilumab) Interleukin-6 receptor antagonist Treatment of adults with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. Kevzara Approved for Polymyalgia Rheumatica
Skyclarys (omaveloxolone) Activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway Treatment of Friedreich ataxia in patients 16 years of age and older. Skyclarys Approved for Friedreich Ataxia
Trodelvy (sacituzumab govitecan-hziy) Trop-2 directed antibody and topoisomerase inhibitor conjugate. For the treatment of adults with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. Trodelvy Drug Monograph
Ophthalmic Disorders
Eylea (aflibercept) Vascular endothelial growth factor inhibitor Treatment of preterm infants with retinopathy of prematurity. Eylea Drug Monograph
Syfovre (pegcetacoplan injection) Complement inhibitor Treatment of geographic atrophy secondary to age-related macular degeneration. Syfovre Drug Monograph