ALYFTREK

批准信原文要点

This Prior Approval supplemental new drug application provides for an expansion of the indication of Alyftrek (VNZ/TEZ/D-IVA) tablets for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 6 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.

批准信原文要点

We also refer to our letter dated December 4, 2025, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we have determined should be included in the labeling for Alyftrek. This supplemental new drug application provides for revisions to the labeling for Alyftrek.

批准信原文要点

We also refer to our letter dated June 16, 2025, notifying you, under Section 505(o)(4) of the FDCA, of new safety information… This information pertains to the risk of increased intracranial pressure disorders. This supplemental new drug application provides for revisions to the labeling for Alyftrek, consistent with our June 16, 2025, letter.