Mesoblast (ASX:MSB) said it aligned with the US Food and Drug Administration (FDA) on the items required for filing a Biologics License Application for its Revascor drug candidate in the treatment of patients with ischemic heart failure with reduced ejection fraction and inflammation, according to a Tuesday Australian bourse filing.
The firm plans to file by the end of the year for accelerated approval in patients with end-stage ischemic heart failure with reduced ejection fraction implanted with a left ventricular assist device.
Formal minutes for the firm's most recent Type B meeting provided by the regulator confirmed alignment with US FDA on items regarding chemistry, manufacturing, and controls, potency assays for commercial product release, as well as proposed design and primary endpoint for the confirmatory trial post-approval.
The firm's shares rose 6% in recent trading on Tuesday.
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