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Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for mavacamten, a new, oral, myosin allosteric modulator for the treatment of obstruction Hypertrophic cardiomyopathy (oHCM), which is a chronic heart disease with a high incidence
Currently, mavacamten's New Drug Application (NDA) for the treatment of symptomatic oHCM is also under review by the US FDA, and the target date of the Prescription Drug User Fee Act (PDUFA) is January 28, 2022
mavacamten is a first-in-class, oral, allosteric myosin inhibitor for the treatment of diseases that are inherently caused by excessive heart contraction and impaired diastolic filling
mavacamten was originally developed to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
The chemical structure of mavacamten (picture source: chemsrc.
Both mavacamten NDA and MAA are based on the results of the key Phase 3 EXPLORER-HCM trial
mavacamten (MYK-461) was developed by MyoKardia
It is worth noting that on August 11, 2020, LianBio, which was incubated by the investment company Perceptive Advisors, was formally established.
Note: The original text has been deleted
Original Source: European Medicines Agency Validates Bristol Myers Squibb's Application for Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy