29.05.2024 13:39:10
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Rocket Pharma Says EC Granted Orphan Medicinal Product Designation For RP-A601
(RTTNews) - Rocket Pharmaceuticals, Inc. (RCKT) Wednesday said the European Commission has granted orphan medicinal product designation for RP-A601, the company's drug candidate to treat plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM).
Currently, there are no curative treatment for PKP2-ACM, an inherited heart disease associated with life-threatening arrhythmias, cardiac structural abnormalities, and sudden cardiac death.
Orphan medicinal product designation by the European Commission qualifies for financial and regulatory benefits including protocol assistance from the European Medicines Agency during clinical development, access to centralized marketing authorization, and a 10-year period of marketing exclusivity after product approval.
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