Gentium withdraws US NDA for defibrotide

19 August 2011

Italian drug developer Gentium SpA (Nasdaq: GENT) saw its shares price plunge 29% to $6.22 on the Nasdaq after it announced that it has voluntarily withdrawn the New Drug Application for its lead investigational drug candidate defibrotide following recent correspondence from the US Food and Drug Administration identifying numerous “Refuse to File” issues regarding the company’s NDA submission.

Gentium acquired rights to the drug, intended for the treatment and/or prevention of hepatic veno-occlusive disease (VOD) from fellow Italian drugmaker Crinos in a deal that cost it around $34 million (The Pharma Letter January 15, 2007). The drug has been granted Orphan Drug status by the FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the FDA to treat VOD.

FDA called for additional reviews

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