ZOKINVY

批准信原文要点

S-003: Updates to the PI to include a new warning under Section 5 WARNINGS AND PRECAUTIONS on QTc Interval Prolongation associated with Zokinvy administration.

批准信原文要点

These Prior Approval sNDAs provide for the following: S-002: Updates to the Prescribing Information (PI) including the modification of information in Section 2 DOSAGE AND ADMINISTRATION, Section 7 DRUG INTERACTIONS, Section 12 CLINICAL PHARMACOLOGY, and Section 17 PATIENT COUNSELING INFORMATION regarding drug interactions with concomitant administration of Zokinvy and inhibitors of CYP3A or CYP2C9. Additional changes were made to other sections of the PI and Patient Package Insert to ensure consistency with this newly added information. These updates are based on the findings from study EIG-LNF-021 conducted to fulfill postmarketing requirement (PMR) 3929-2 to assess the effect of concomitant administration of a CYP2C9 inhibitor on the pharmacokinetics of lonafarnib. S-003: Updates to the PI to include a new warning under Section 5 WARNINGS AND PRECAUTIONS on QTc Interval Prolongation associated with Zokinvy administration. Additional changes were made to other sections of the PI and Patient Package Insert to ensure consistency with this newly added information. These updates are based on the findings from study EIG-LNF-022, a study conducted to fulfill PMR 3929-3 to evaluate the effect of lonafarnib on QT interval prolongation.