A new drug arrives for a cardiomyopathy © ANSA/Ansa
The European Commission (EC) has approved a new drug for symptomatic hypertrophic obstructive cardiomyopathy, a heart disease that is often hereditary, debilitating and progressive and which can cause patients symptoms such as shortness of breath, loss of consciousness, dizziness up to serious complications even lethal .
“Mavacamten is the first and only selective allosteric and reversible cardiac myosin inhibitor approved in the Member States* of the European Union (EU) and the first cardiac myosin inhibitor that addresses the pathophysiological mechanisms underlying hypertrophic obstructive cardiomyopathy. European Commission of mavacamten builds on positive efficacy and safety results from Phase 3 studies.” “Hypertrophic obstructive cardiomyopathy, often genetically determined, causes an increase in the thickness of the walls of the left ventricle of the heart – explains Gianfranco Sinagra, Director of the Cardiothoracovascular Department of the Integrated University Health Authority of Trieste, Full Professor of Cardiology and Director of the School of Specialization in Cardiovascular at the University of Trieste – Despite being a rare disease, hypertrophic obstructive cardiomyopathy is among the top three causes of sudden juvenile death among athletes Life-threatening ventricular arrhythmias can occur in young people and in athletes, without being preceded by premonitory symptoms. The disease, in fact, can be completely asymptomatic, or present transient symptoms such as dyspnoea, fatigue, loss of consciousness”. “It is the most frequent familial genetic heart disease, in fact in about 50-60% of cases it is genetically determined – continues Prof. Sinagra -. This allows you to shift attention from the patient to family members, allowing for early diagnosis and preventive approaches .
The approval of therapies such as mavacantem is undoubtedly an important step forward that will allow us to give concrete answers to people’s needs”.
“It is estimated that there are over 100 thousand people affected by hypertrophic cardiomyopathy in Italy. Of these, however, only about 15 thousand have probably received a correct diagnosis” says Iacopo Olivotto, Full Professor of Cardiology at the University of Florence and Director of Pediatric Cardiology of the Meyer IRCCS University Hospital.
“The EXPLORER-HCM study is a milestone, because it is the first trial that has led to the approval of a drug expressly developed for the treatment of hypertrophic cardiomyopathy, a disease that has so far been orphaned on a pharmacological level” continues Olivotto, who is Principal Investigator of the EXPLORER-HCM study. Patients in Europe who will now have the treatment option mavacamten, a first-in-class inhibitor of cardiac myosin that targets the underlying pathophysiology of symptomatic hypertrophic obstructive cardiomyopathy,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb “We are proud to bring this innovative treatment to more patients around the world and reaffirm our global commitment to transforming patients’ lives through science.”
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