Camzyos (mavacamten) for Obstructive hypertrophic cardiomyopathy, adolescents
The FDA is expected to decide on Camzyos for Obstructive hypertrophic cardiomyopathy, adolescents by September 30, 2026, under a sNDA from Bristol Myers Squibb.
What is being decided
Bristol Myers Squibb has a sNDA under FDA review for Camzyos (mavacamten) in Obstructive hypertrophic cardiomyopathy, adolescents. Already approved for adults; this application would extend use to ages 12 to 17.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
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Frequently asked questions
When will the FDA decide on Camzyos?
The FDA's target decision date (PDUFA date) for Camzyos in Obstructive hypertrophic cardiomyopathy, adolescents is September 30, 2026, disclosed by Bristol Myers Squibb. The agency can act before this date and occasionally runs past it.
What is Camzyos being reviewed for?
Bristol Myers Squibb submitted a sNDA for Camzyos in Obstructive hypertrophic cardiomyopathy, adolescents. Already approved for adults; this application would extend use to ages 12 to 17.
What happens after the Camzyos decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from BMS press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.