Bristol Myers Analyst Says FDA Update Is A Win For Camzyos With Simpler Use, Broader Reach

On Friday, the Food and Drug Administration updated the U.S. Prescribing Information for Bristol Myers Squibb & Co’s BMY Camzyos (mavacamten), simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications.

Camzyos is the first and only FDA-approved cardiac myosin inhibitor for adults with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

FDA-approved updates include reduced frequency of required echo monitoring from once every 12 weeks to every 6 months for patients with left ventricular ejection fraction (LVEF) ≥55% and a Valsalva left ventricular outflow tract (LVOT) gradient <30 mmHg (or Valsalva LVOT ≥30 mmHg without up-titration) who have reached the maintenance phase (at Week 12 or later).

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Additionally, Camzyos is no longer contraindicated with moderate CYP2C19 and strong CYP3A4 inhibitors, which were adjusted to drug interactions.

The approved label update is supported by long-term clinical and real-world data, including analyses of results from the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program, real-world experience from three single-center studies, and ongoing clinical data reinforcing Camzyos’s safety profile over the past 3.5 years.

William Bliar analyst Matt Phipps writes the update is largely in line with that hinted by management and supported by real-world evidence, which will reduce the burden for physicians managing patients on Camzyos.

Phipps also views the update as timely ahead of the assumed approval of Cytokinetic Inc’s CYTK aficamten, with a PDUFA date of September 26.

The analyst says they are now waiting for details on the monitoring requirements for aficamten to determine potential areas of differentiation and how this may impact new market share in the coming years, assuming approval on September 26.

Last week, Bristol Myers Squibb announced topline data from the Phase 3 ODYSSEY-HCM trial of Camzyos (mavacamten) for symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM).

The trial did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2).

No new safety signals were observed.

Price Action: BMY stock was down 0.7% at $48.83 at last check Monday.

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