Mesoblast (MESO) has filed a request for a Type B meeting with the FDA to discuss the accelerated approval pathway for Revascor® in treating ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. The meeting, expected this quarter, will be held under Mesoblast's Regenerative Medicines Advanced Therapy (RMAT) designation.
In a previous Type B meeting, the FDA indicated Mesoblast's eligibility to file for accelerated approval for Revascor in end-stage HFrEF patients, based on data from two randomized controlled trials. The FDA also specified the requirement for a single confirmatory trial in class II/III patients with ischemic HFrEF and inflammation post-approval.
The upcoming meeting aims to obtain FDA feedback on chemistry, manufacturing & controls (CMC), align on potency assays for commercial product release, and discuss the proposed design and primary endpoint for the confirmatory trial.
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