CAMZYOS

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Camzyos US labeling with the efficacy, safety and pharmacokinetics results from the clinical pediatric study, CV027010 ... the extension of the indication to include pediatric patients weighing 30 kg or more with obstructive hypertrophic cardiomyopathy ... the addition of a 1 mg capsule strength ... and proposed modifications to the approved Camzyos REMS.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes to the labeling and proposed modifications to the approved Camzyos risk evaluation and mitigation strategy (REMS): • Removal of contraindications for moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors • Update descriptions of contraindicated medications and medications requiring dose adjustments when used concomitantly with Camzyos • Advise that Camzyos may be interrupted for “short-term” use (when Camzyos dose modification is not feasible) of a weak to moderate CYP2C19 inhibitor • Update the echocardiogram monitoring schedule from 12 weeks to 3 - 6 months for patients on a stable dose of Camzyos in the maintenance phase • Add a post-exercise LVOT gradient assessment that may be considered to further titrate symptomatic patients with normal or near normal Valsalva gradients • Extend the dispensing limit from 35-day to 90-day supply for patients beyond the first year of treatment with Camzyos.

批准信原文要点

This Prior Approval sNDA provides for revisions to labeling with respect to concomitant use of combined hormonal contraceptives as well as revisions in the Overdosage section and the use of activated charcoal.

批准信原文要点

This Prior Approval supplemental new drug application provides for proposed modifications to the approved Camzyos risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Prior Approval supplemental new drug application provides for an update to the Camzyos Package Insert with the efficacy and safety results from the VALOR-HCM study, provides the final report for your postmarketing study and proposed modifications to the approved Camzyos r…

批准信原文要点

This Changes Being Effected sNDA provides for proposed modifications to the approved Camzyos risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Changes Being Effected sNDA provides for proposed modifications to the approved Camzyos risk evaluation and mitigation strategy (REMS).