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ARTICLE | Company News

Zavesca receives complete response

March 10, 2010 2:10 AM UTC

FDA issued a complete response letter for an sNDA from Actelion Ltd. (SIX:ATLN) for Zavesca miglustat to treat progressive neurological manifestations in patients with Niemann-Pick type C disease. The agency asked Actelion to provide additional preclinical and clinical information. In January, FDA's Endocrinologic and Metabolic Drugs Advisory Committee backed approval of the drug for the Orphan neurodegenerative genetic disorder even though panel members were split on whether the clinical data included in Actelion's application met the legal hurdle for "significant evidence" of efficacy. ...