Capricor Therapeutics Granted Orphan Drug And ATMP Status For Deramiocel By EMA
Capricor Therapeutics Granted Orphan Drug And ATMP Status For Deramiocel By EMA
Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD).
capricor therapeutics（纳斯达克：CAPR）是一家开发基于电芯和外泌体治疗稀有疾病的生物技术公司，今天宣布欧洲药品管理局（EMA）已将孤儿药和爱文思控股药品（ATMP）称号授予其主要资产deramiocel，用于治疗杜氏肌营养不良症（DMD）。
The Orphan Drug designation provides Capricor with several benefits that support the development of deramiocel in Europe, including market exclusivity for 10 years if approval is granted and substantially reduced regulatory fees. The ATMP designation provides substantial regulatory support to assist in the development of cell-based therapies. The additional support can potentially reduce time to market, streamline development, and open up access to critical resources, making it an invaluable tool for companies working on innovative therapies.
孤儿药称号为capricor提供了多个支持deramiocel在欧洲开发的好处，包括在批准后拥有10年的市场独占权及大幅减少的监管费用。ATMP称号则提供了 substantial监管支持，以协助开发基于电芯的疗法。额外的支持可能会减少上市时间，简化开发流程，并开放获取关键资源，从而成为致力于创新疗法的公司的宝贵工具。
