Mesoblast Heart Failure Cell Therapy Receives Orphan Drug Designation From FDA for Prevention of Gastrointestinal Bleeding in Patients With Left Ventricular Assist Devices
Mesoblast Limited - American Depositary Shares (MESO)
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Source: GlobeNewswire
NEW YORK and MELBOURNE, Australia, June 24, 2019 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq: MESO), global leader in cellular medicines for inflammatory diseases, announced today that the United States Food and Drug Administration (FDA) has granted the company’s product candidate, rexlemestrocel-L, Orphan Drug Designation for prevention of post-implantation mucosal bleeding in end-stage chronic heart failure (CHF) patients who require a left ventricular assist device (LVAD). Mesoblast Chief Executive Dr Silviu Itescu said: “We are very pleased that the FDA has granted our heart failure cell therapy product candidate, Revascor, Orphan Drug designation for use in patients with LVADs to prevent mucosal bleeding, including from the gastrointestinal (GI) tract. We look forward to our upcoming meeting with the FDA to discuss a potential approval pathway under the product’s existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition.
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