Sanofi's Multaq (Dronedarone) Approved in China for Sinus Rhythm Patients with History of Atrial Fibrillation to Reduce Hospitalization Risk

On December 22, Sanofi announced that the National Medical Products Administration (NMPA) of China had officially approved Multaq (dronedarone hydrochloride tablets) for use in patients with a history of paroxysmal or persistent atrial fibrillation (AF) who are in sinus rhythm, to reduce the risk of hospitalization due to atrial fibrillation. According to the press release, Multaq is the only antiarrhythmic drug proven to significantly reduce the risk of cardiovascular events leading to hospitalization or all-cause mortality in patients with atrial fibrillation, providing a long-term effective and safer treatment option for AF patients.

Atrial fibrillation (AF) refers to the loss of normal rhythm in atrial contractions, typically characterized by an irregular and rapid heart rate, and is a common type of arrhythmia. China currently has nearly 10 million AF patients, two-thirds of whom experience discomfort symptoms such as palpitations, chest tightness, shortness of breath, fatigue, and reduced exercise tolerance, while one-third show no obvious symptoms and are often discovered during routine physical exams or when electrocardiograms are performed for other reasons. Rhythm control, which involves restoring and maintaining sinus rhythm, is an important method for effectively managing symptoms in AF patients. After cardioversion, all AF patients face the issue of recurrence after a period of time. Long-term rhythm control with antiarrhythmic drugs can significantly delay recurrence; however, due to the serious and numerous side effects of some medications, patients are unable to take them long-term, leading to accelerated deterioration of their condition.

As a new type of antiarrhythmic drug, Multaq (Mai Da Long) is more effective in maintaining sinus rhythm and reducing the recurrence of atrial fibrillation (AF). Evidence shows that it can maintain sinus rhythm for up to 158 days, providing long-term, stable support for patients with paroxysmal or persistent AF after cardioversion. The ATHENA study demonstrated that Multaq reduced the risk of cardiovascular hospitalization or all-cause mortality by 24% in patients with AF. This study was a randomized, double-blind, international multicenter, placebo-controlled clinical trial involving 4,628 patients with a new history of AF/flutter who were in sinus rhythm or about to be converted to sinus rhythm.

Studies show that Multaq is more effective in maintaining sinus rhythm and reducing the recurrence of atrial fibrillation. Moreover, several authoritative guidelines worldwide recommend Multaq as the first-line long-term rhythm control drug for patients with paroxysmal/persistent atrial fibrillation, including the 2020 European Society of Cardiology guidelines, which state that Multaq has the most comprehensive safety data and thus may be the most suitable first choice for patients. To date, more than 15 million patients globally have used Multaq.