Bristol Myers Gets Speedy FDA Review of Camzyos in Adolescents
By Colin Kellaher
Bristol Myers Squibb has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Camzyos heart drug for adolescents with symptomatic obstructive hypertrophic cardiomyopathy, or oHCM.
Bristol Myers on Monday said the FDA has set a target action date of Sept. 30 for the application, adding that a green light would make Camzyos the first cardiac myosin inhibitor to treat adolescents with oHCM, a primary cardiac disorder where the heart muscle thickens, blocking or reducing blood flow from the left ventricle.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
The agency approved Camzyos in April 2022 for adults with oHCM.
Princeton, N.J., drugmaker Bristol Myers reported Camzyos sales of nearly $1.07 billion last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 01, 2026 07:43 ET (11:43 GMT)
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