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Home Drug Development FDA Approvals

Camzyos, Possible Mega Cardiac Drug Given Green Light By FDA

Content Team by Content Team
3rd May 2022
in FDA Approvals, News
authorisation for roxadustat in China

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Bristol Myers Squibb has gained approval for one of the year’s most anticipated medications, following a brief delay in November. Camzyos, a drug developed by Bristol Myers Squibb, was approved by the FDA to cure symptomatic obstructive hypertrophic cardiomyopathy, or obstructive HCM. Formerly known as mavacamten, the medicine could be a blockbuster addition to BMS’ cardiovascular stable, which is in desperate need of new blood as top-seller Eliquis’ patent expires later this decade.

Camzyos was a key component of BMS’s $13.1 billion MyoKardia purchase in 2020. BMS reported in January that the HCM medicine is one of four current or upcoming Bristol products that could generate maximum revenues of much more than $4 billion alone or in combination, as per the firm. Following the loss of exclusivity for Revlimid, BMS is banking on Camzyos as well as other drugs to help cushion the impact.

In the past, HCM treatment has centred on symptom relief with medications like beta-blockers or calcium channel blockers, according to chief medical officer at Bristol Myers, Samit Hirawat, M.D. Camzyos, on the other hand, works by inhibiting cardiac myosin to improve functional and clinical outcomes, as per him. Hypertrophic cardiomyopathy causes the heart’s walls and septum to enlarge as muscle fibres expand and multiply. According to Hirawat, this reduces the organ’s blood storage capacity, increasing the heart’s workload.

Shortness of breath, weakness, weariness, and the inability to undertake daily exercise like walking up stairs, weight lifting, or playing sports are all symptoms of HCM. According to Hirawat, Camzyos acts by attaching to the protein myosin and inhibiting the actin-myosin connections that cause HCM.

Hirawat explained that hypertrophic cardiomyopathy is a condition that goes undiagnosed for a long time. Many people are diagnosed late in life or remain untreated for extended periods of time. Because HCM is often overlooked, Hirawat believes that education will be critical to the drug’s success. A significant number of people in the area are going undiagnosed with hypertrophic cardiomyopathy, he said, adding that even those that have been symptomatic due to, for instance, breathlessness or any other symptomatology may not pursue a cardiologist’s opinion.

In November, Bristol launched its “Could It Be HCM” website, which offers symptom information and patient resources. Hirawat said the company is exploring more public education programmes. The FDA made its decision based on results from Myokardia’s phase 3 Explorer-HCM research, which demonstrated that the drug improved symptoms, functional ability, and quality of life when compared to placebo.

According to the company, Camzyos will only be provided through a risk management and mitigation strategy programme. It comes with a boxed warning about the risk of heart failure. This is because the medication “relaxes” the heart, according to Hirawat. As per the CMO, if the heart becomes overly calm, its output will drop as assessed by the injection fraction.

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