Kiadis Pharma receives FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ATIR101™
Amsterdam-Duivendrecht, The Netherlands, September 20, 2017 – Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients suffering from blood cancers and inherited blood disorders, today announces that the US Food and Drug Administration (FDA) has granted ATIR101™, Kiadis Pharma's lead investigational product for blood cancers, the Regenerative Medicine Advanced Therapy (RMAT) designation.
Arthur Lahr, CEO of Kiadis Pharma, commented: "To receive the RMAT designation from the FDA is an important milestone for Kiadis Pharma and a recognition by the FDA of the significant potential for ATIR101™ to help patients receive safer and more effective bone marrow transplantations. RMAT is analogous to the Breakthrough Therapy designation, and a clear validation of ATIR101™ towards doctors and investors. We are now going to work even closer with the FDA to agree a path to make this cell therapy treatment available for patients in the US as soon as possible. In Europe ATIR101™ was filed for registration in April 2017 and we continue to prepare the Company for the potential European launch in 2019."
The RMAT pathway is analogous to the Breakthrough Therapy designation designed for traditional drug candidates and medical devices, and was specifically created by the US Congress in 2016 to get important new cell therapy and advanced medicinal products to the patient earlier. Just like the Breakthrough designation, it allows companies developing regenerative medicine therapies to interact with the FDA more frequently in the clinical testing process, and RMAT-designated products may be eligible for priority review and accelerated approval.