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Dr Jay Edelberg Explains Preventive Efficacy and Potential FDA Approval of Mavacamten
We are really excited about the progress we have seen in the EXPLORER-HCM trial, and after the results are published in the first half of 2020, we will quickly begin conversations to seek FDA approval of mavacamten, said Jay Edelberg, MD, PhD, senior vice president of Clinical Development at MyoKardia.
We are really excited about the progress we have seen in the EXPLORER-HCM trial, and after the results are published in the first half of 2020, we will quickly begin conversations to seek FDA approval of mavacamten, said Jay Edelberg, MD, PhD, senior vice president of Clinical Development at MyoKardia.
Transcript
What is the importance of the Cleveland Clinic study assessing mavacamten as an alternative to septal reduction therapy?
We said that for some patients, their only option for getting any type of symptomatic improvement is surgery. This is actually a surgery where the septum is actually debulked—it's an open heart procedure where a piece of the septum is surgically removed, or alternatively, in a cardiac catheterization procedure, alcohol is injected into the sceptile artery to actually induce a targeted myocardial infarction. We think that mavacamten can offer an important alternative for these patients. So, working with the Cleveland Clinic, and other great centers, which focus on being able to provide septal reduction therapy, we're looking forward to being able to start a study where we can show show that mavacamten can prevent the need for surgery in many patients.
What is the overall time frame for mavacamten seeking FDA approval?
We're really excited about the progress that we're seeing in EXPLORER-HCM. We're looking for those results in the first half of 2020. With that, we’ll quickly move to a discussion with the FDA and get ready for filing mavacamten for its first indication. We're looking forward to that quickly there afterwards and then seeking the review with the FDA for approval.
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