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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- Vaccination Recommendations for Updated 2024-2025 COVID-19 Vaccines (online only)
RELEASE
The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.1
Buprenorphine is the maintenance treatment of choice for most patients with opioid use disorder. To prevent severe opioid withdrawal, patients must already be receiving treatment with buprenorphine or undergo a trial with a short-acting transmucosal product before a long-acting formulation can be initiated.2 The labeling changes allow for a first subcutaneous dose of Sublocade to be given after a single transmucosal test dose of buprenorphine; previously, use of transmucosal buprenorphine for at least 7 days had been …