The FDA has approved Alyftrek (Vertex), an oral fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators vanzacaftor, tezacaftor, and deutivacaftor, for once-daily treatment of cystic fibrosis (CF) in patients ≥6 years old who have at least one F508del mutation or another responsive mutation in the CFTR gene. This is the first approval for vanzacaftor and for deutivacaftor, a deuterated form of ivacaftor. Trikafta, a twice-daily oral fixed-dose combination of elexacaftor, tezacaftor, and ivacaftor, is FDA-approved for the same indication in patients ≥2 years old.
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RELEASE
The FDA has approved Merilog (Sanofi), a biosimilar to rapid-acting insulin aspart (NovoLog), for treatment of patients with type 1 or type 2 diabetes. Merilog is the first rapid-acting insulin biosimilar product to become available in the US.
REGULATORY STATUS — A biosimilar is a biologic product that is highly similar in composition, strength, and biological properties and has no clinically meaningful differences in safety, purity, and potency to the FDA-approved reference product. Although Merilog has been designated as a biosimilar to the reference product NovoLog, it has not received interchangeability status from the FDA. Merilog cannot be substituted as a lower-cost alternative to NovoLog by the pharmacist without permission from the prescriber.
CLINICAL STUDIES …