FDA Approves New Oral Tx for Rare Heart Condition – Camzyos

Over the years few new specialty therapies have been approved for Cardiology conditions. That may be about to finally change with a recent FDA approval.

Last week the FDA approved a new ORAL specialty therapy, Camzyos (mavacamten) from Bristol Myers Squibb (via MyoKardia, Inc., a wholly-owned subsidiary), indicated for (deep breath now) the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.

Obstructive hypertrophic cardiomyopathy is an often un/mis-diagnosed condition in which the heart muscle thickens and impairs its ability to pump blood. Patients often have symptoms like those seen with heart failure. Symptoms have generally been treated with beta blockers and calcium channel blockers. Camzyos helps heart muscle fibers relax more in between beats, allowing more blood entering the ventricles to be pumped out when they contract helping to resolve symptoms. Echocardiogram assessments of left ventricular ejection fraction LVEF are required before and during treatment.

BMS announced a list price of $89,500 for a year of treatment. BMS also forecasted that they see sales in excess of $2 billion by 2029, slightly under analysts’ consensus.

BMS also indicated that Camzyos will only be available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program due to meaningful risk of heart failure due to systolic dysfunction.

Prescribers must be certified by enrolling in the REMS Program. Additionally, patients must also enroll in the REMS Program and agree to comply with ongoing monitoring requirements.

BMS also announced that Camzyos will be dispensed only to REMS enrolled patients through select, certified specialty pharmacies in a limited distribution program.

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FDA approves new drug to improve heart function in adults with rare heart condition

FDA has approved Camzyos (mavacamten) capsules to treat adults with symptomatic New York Heart Association (NYHA)External Link Disclaimer class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms.

Disease or Condition
oHCM is a rare disease that occurs when the heart muscle thickens, mostly in the septum (the heart wall that separates its right and left sides) and obstructs blood flow from the heart to the rest of the body.

The severity of oHCM varies, but it can cause serious symptoms and death. Symptoms include palpitations (the sensation the heart is pounding), shortness of breath, swelling of the legs, and decreased exercise capacity, which significantly impact daily activities and quality of life.

The effectiveness and safety of Camzyos to treat NYHA class II-III oHCM was studied in adults who were randomly assigned to receive Camzyos or a placebo for 30 weeks. At the end of the study, 37% of participants treated with Camzyos improved on an endpoint measuring exercise capacity and symptoms, compared to 17% of participants in the placebo group.

Safety Information
Camzyos reduces contraction of the heart muscle, which can cause heart failure or totally block functioning of the ventricles (lower chambers of the heart). Patients who have a serious intercurrent illness (such as a serious infection) or arrhythmia (atrial fibrillation or other uncontrolled fast heart rhythm abnormality) are at greater risk of developing impaired heart muscle contraction and heart failure with Camzyos.

Because of the risk for heart failure, patients treated with Camzyos must be monitored with echocardiograms, an imaging test that shows how well the heart is working. Patients must also avoid certain prescription and over-the-counter medicines that interfere with the metabolism (breakdown) of Camzyos.

Because of the potential for developing symptomatic or life-threatening heart failure if monitoring is not followed or if Camzyos is used with medicines that impair its metabolism, Camzyos is only available through a restricted program called the Camzyos Risk Evaluation and Mitigation Strategy (REMS). The REMS program helps ensure safe use by lowering the risk of heart failure due to impaired heart muscle contraction.


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