Everest Medicines today announced that China’s National Medical Products Administration (NMPA) has approved CARDAMYST(R) (etripamil) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. As Everest's first innovative therapy approved in the cardiovascular field, CARDAMYST further expands the Company‘s cardiovascular portfolio. The approval marks another important milestone in the execution of Everest's commercialization strategy and reinforces the Company's capability to bring innovative therapies to patients in China.CARDAMYST (etripamil) nasal spray is a novel, rapid-acting calcium channel blocker administered as needed via a convenient, portable nasal spray. It offers rapid onset of action, favorable tolerability, and the potential for at-home self-administration, enhancing patient accessibility. CARDAMYST is currently the only self-administered treatment for adults with PSVT to rapidly treat episodes. Treatment effects observed as early as five minutes after administration, with nearly two-thirds of patients achieving conversion to sinus rhythm within 30 minutes, reducing the need for emergency medical interventions and filling a critical gap in out-of-hospital, self-administered treatment options for acute symptomatic episodes of PSVT in China.
PSVT is a type of tachyarrhythmia characterized by the sudden onset and termination of episodes of rapid, regular heart rhythm. Approximately 2.3 to 4 per 1,000 individuals are affected by PSVT, representing an estimated 3 to 6 million patients in China. During episodes, the heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The management of acute PSVT episodes in China has long relied primarily on hospital-based emergency care, highlighting the need for an on-demand treatment option that patients can self-administer outside of healthcare settings.
“The approval of CARDAMYST addresses a critical unmet need by introducing the first innovative therapy that enables patients to self-administer treatment for acute PSVT episodes in China,” said Professor Changsheng Ma, M.D., Principal Investigator of the Phase III JX02002 study, Director of Cardiology Department at Beijing Anzhen Hospital, and President of the Chinese Society of Cardiology, Chinese Medical Association, “Both the global pivotal Phase III RAPID trial and the China Phase III JX02002 study demonstrated its rapid onset, robust efficacy, and favorable safety profile. We believe this innovative therapy has the potential to transform the treatment paradigm for acute PSVT episodes by enabling timely, patient-initiated treatment, reducing the need for emergency medical intervention, and ultimately improving patients' quality of life.”
“The approval of CARDAMYST marks an important milestone, introducing the first out-of-hospital, patient-administered treatment option for acute PSVT episodes in China,” said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “As the only innovative therapy currently available that enables patients to self-administer treatment for PSVT episodes outside of healthcare settings, CARDAMYST offers a new on-demand treatment option.
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