Vericel Corp. (VCEL)

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Vericel Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Ixmyelocel-T for the Treatment of Advanced Heart Failure Due to Ischemic Dilated Cardiomyopathy
Ixmyelocel-T is the First Therapy to Receive the RMAT Designation for the Treatment of a Serious Cardiovascular Disease
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May 10, 2017 07:00 ET | Source: Vericel Corporation

CAMBRIDGE, Mass., May 10, 2017 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of autologous expanded cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation for ixmyelocel-T, an investigational product for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy. The RMAT designation is a new expedited program established under the 21st Century Cures Act to foster the development and approval of regenerative medicine products intended for the treatment of serious diseases and conditions.

“Being among the first products to receive the RMAT designation, in addition to the recently granted Fast Track designation, highlights both the significance of the results from the ixmyelocel-T Phase 2b ixCELL-DCM clinical study and the unmet medical need for improved therapies to treat advanced heart failure due to ischemic dilated cardiomyopathy,” said Nick Colangelo, president and CEO of Vericel. "While our focus remains on our core commercial business, achieving the RMAT and Fast Track designations enhances the value of ixmyelocel-T to potential partners since they provide a pathway for expedited development and approval.”

The RMAT designation is an expedited drug development and review program for regenerative medicine therapies. The purpose of the program is to get important new therapies for serious or life-threatening conditions to the patient earlier. A regenerative medicine is eligible for the designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition.

In addition to providing an avenue for increased and earlier interactions with the FDA, designated products may be eligible for priority review and accelerated approval. As described in the 21st Century Cures Act, RMAT-designated products may be eligible for accelerated approval based on surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of clinical sites. The sponsor of a regenerative advanced therapy that is granted accelerated approval and is subject to post-approval requirements may, as appropriate, fulfill such requirements through submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence such as electronic health records, through the collection of larger confirmatory datasets, or through post-approval monitoring of all patients treated with the therapy prior to approval. For more information on RMAT designation, visit the FDA website (https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm).


https://globenewswire.com/news-release/2017/05/10/981696/0/en/Vericel-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-Ixmyelocel-T-for-the-Treatment-of-Advanced-Heart-Failure-Due-to-Ischemic-Dilated-Cardiomyopathy.html