Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb’s (BMS; NYSE: BMY) erythropoietic aid Reblozyl (luspatercept) and BeiGene’s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to Fineline Info & Tech analysis. The approvals mark significant milestones for both drugs in the Latin American market.
Drug Profiles and Indications
Reblozyl is indicated for the treatment of anemia associated with beta thalassemia, myelodysplastic syndromes with ring sideroblasts (MDS-RS), and myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). The drug is a recombinant fusion protein that acts as an erythroid maturation agent by binding to several members of the transforming growth factor-β (TGF-β) superfamily of ligands, which is upstream of the Smad2/3 pathway that displays elevated signaling in beta thalassemia and MDS.
Brukinsa, developed by BeiGene, is a BTK inhibitor that inhibits the proliferation and survival of malignant B lymphocytes by covalently binding to the active site of BTK, an enzyme crucial for B lymphocyte proliferation, trafficking, chemotaxis, and adhesion. Last month, BeiGene announced several Latin American approvals for Brukinsa in mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and Waldenström’s macroglobulinemia (WM).
Market and Competitive Landscape
Fineline Info & Tech analysis indicates that this is the third regulatory approval for BMS’s Reblozyl in Latin America, following approvals in Brazil and Uruguay. Meanwhile, BeiGene’s Brukinsa will enter Peru’s competitive BTK inhibitor market, where it will compete with Johnson & Johnson’s (J&J; NYSE: JNJ) Imbruvica (ibrutinib), AstraZeneca’s (AZ, NASDAQ: AZN) Calquence (acalabrutinib), and several ibrutinib generics. Brukinsa is already available in Argentina, Mexico, Brazil, Chile, Ecuador, El Salvador, Paraguay, and Uruguay.-Fineline Info & Tech
