Cytokinetics Granted European Orphan Designation for Reldesemtiv for the Treatment of Amyotrophic Lateral Sclerosis

About this update from Cytokinetics, Incorporated

[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., March 04, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation to reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS). Previously reldesemtiv was granted orphan drug designation for the treatment of ALS by the U.S. Food & Drug Administration. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people with ALS, SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.\n Orphan medicinal product designation is adopted by the European Commission based on an opinion by the EMA’s Committee for Orphan Medicinal Products (COMP). Orphan medicinal product designation is granted by the EMA to medicines intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating disease affecting fewer than 5 in 10,000 persons in the European Union, or for which it is unlikely that the costs associated with the development and commercialization of the medicine would be recovered by expected sales under normal market conditions without the incentives provided by the designation. The designation offers potential incentives, which may include a ten-year period of EU marketing exclusivity from the date of marketing authorization, EU-funded research, protocol assistance and fee reductions. “Receipt of orphan status in Europe builds on the orphan status we received in the U.S., reinforcing the continued unmet need for patients in these key regions who are combatting weakening muscle function and the relentless challenges related to ALS,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. About Reldesemtiv Skeletal muscle contractility is driven by the sarcomere, the fundamental unit of skeletal muscle contraction and a highly ordered cytoskeletal structure composed of several key proteins. Skeletal muscle myosin is the motor protein that converts chemical energy into mechanical force through its interaction with actin. A set of regulatory proteins, which includes tropomyosin and several types of troponin, make the actin-myosin interaction dependent on changes in intracellular calcium leve...

More updates from Cytokinetics, Incorporated