Keywords: Actelion, Zavesca, Niemann-pick disease, FDA

US FDA calls for more data on Actelion’s Zavesca for Niemann-Pick type C disease

Article | 10 March 2010

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Swiss biotechnology firm Actelion revealed yesterday afternoon that it has received a complete response letter from the US Food and Drug Administration for its supplemental New Drug Application for Zavesca (miglustat) requesting additional preclinical and clinical information. The sNDA had applied for approval of the drug – which is already marketed gor Gaucher’s disease - for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C (NP-C) disease, a rare, neurodegenerative genetic disorder.

The news had little impact of the firm’s stock, which rose a modest 0.5% to 47.85 Swiss francs last night, in line with the 0.5% rise in the Stoxx Europe 600 healthcare index, as some analysts said the risk of Actelion becoming a takeover target is on the rise. Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.