Catalyst Pharma's Infantile Spasms Therapy CPP-115 Gets EC Orphan Drug Status

(RTTNews.com) - Catalyst Pharmaceuticals Partners Inc. (CPRX) Monday reported that its West Syndrome, or infantile spasms, therapy CPP-115 was given orphan medicinal product designation by the European Commission upon the recommendation of the European Medicines Agency, or EMA, Committee on Orphan Medicinal Products, or COMP. The decision was based on preclinical data which showed CPP-115 as being active for a longer time, and resulting in fewer retinal side effects.

Patrick McEnany, Catalyst's chief executive officer, said "We have hit another major milestone in our efforts to advance this clinically important treatment for patients around the world. Obtaining an orphan designation for CPP-115 in the European Union (EU) is an important step that builds upon our recent progress with CPP-115, including the grant of Fast Track development program designation by the U.S. Food and Drug Administration (FDA) for cocaine dependency and commencement of a first-in-man Phase I(a) safety study."

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Catalyst Pharma's Infantile Spasms Therapy CPP-115 Gets EC Orphan Drug Status