First Cushing's drug, Novartis' Signifor, approved in the EU

The European Commission has approved Swiss drug major Novartis’ (NOVN: VX) Signifor (pasireotide) for the treatment of adult patients with Cushing's disease, a rare hormonal disorder, for whom surgery is not an option or for whom surgery has failed.

Signifor is the first medicine to be approved in the European Union targeting Cushing's disease, the company noted in a press statement this morning. Last year Novartis withdrew its New Drug Application for Signifor in the USA due to a problem in its chemistry, manufacturing and controls (CMC) section. However, Corcept Therapeutics gained FDA approval for its Cushing’s drug Korlym (mifepristone) earlier this year (The Pharma Letter February 20).

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