Novartis wins EU approval for Cushing’s disease drug

Novartis has won European regulatory approval for Signifor, its groundbreaking new treatment for Cushing's disease.

The European Commission has ratified the drug for use among adult patients for whom surgery is not an option or for whom surgery has failed, making it the first product approved for this disease in Europe.

Cushing's disease is a debilitating endocrine disorder caused by underlying pituitary tumours which trigger excess cortisol, causing obesity, fatigue, weakness, depression and anxiety among patients.

Data from phase III trials shows that treatment with Signifor can lead to a rapid and sustained decrease in mean cortisol levels, thus creating improvements in key clinical manifestations of the disease.

Herve Hoppenot, president at Novartis Oncology, said: "By focusing research efforts on our understanding of this rare disease where there is significant unmet need, we have been able to successfully bring a novel treatment option to patients in the EU."

Earlier this month, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Jakavi, Novartis' new therapy for disease-related splenomegaly or symptoms in myelofibrosis patients.