FDA provides pathway to BLA approval for chronic heart failure cell therapy

FDA provides pathway to BLA approval for chronic heart failure cell therapy

The has established to marketing for Revascor, is an allogeneic mesenchymal cell therapy for injection the heart muscle in with moderate to advanced end-stage chronic HF. reported “positive outcomes” from recent meeting with FDA provides pathway the to support product authorization biologics license application.

NEW YORK and MELBOURNE, Australia, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, announced today positive outcomes from its recent meeting with the United States Food and Drug Administration (FDA) on the pathway for marketing authorization of its allogeneic cell therapy product candidate Revascor in end-stage heart failure patients implanted with a left ventricular assist device (LVAD). The confirmatory trial is planned to be conducted with the International Center for Health Outcomes Innovation Research (InCHOIR) at the Icahn School end stage heart failure symptoms of Medicine at Mount Sinai in New York, in line with an existing Memorandum of Understanding. Mesoblast Chief Executive Dr Silviu Itescu said: “The FDA guidance on the pathway to registration for our heart failure product candidate in LVAD patients is a major step forward for our cardiovascular program. We will work closely with the FDA and InCHOIR to generate the confirmatory clinical data needed for full marketing approval of Revascor in the prevention of this life-threatening inflammatory complication of an LVAD implant in end-stage heart failure patients.

This large Scandinavian cohort study the effectiveness inhibitors in routine clinical Use was not associated with reduced risk the outcome major events any FDA Provides Guidance Use of sodium the components this composite outcome (the outcomes myocardial infarction, and death). By contrast.

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