EMA panel backs Novartis Cushing's disease drug; Glivec label change

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Swiss drug major Novartis’ (NOVN: VX) Signifor (pasireotide), a new medicine intended for the treatment of Cushing’s disease in patients who cannot have surgery or for whom surgery has not been successful.

"We are pleased with the decision by the CHMP in support of pasireotide in the European Union," said Herve Hoppenot, president, Novartis Oncology, adding: "We are now one step closer to being able to offer patients in Europe the first approved medical treatment for Cushing's disease."

Cushing’s disease is a very rare, debilitating and life-threatening disease, where a small tumor of the pituitary (an endocrine gland) makes too much of the hormone adrenocorticotrophin (ACTH), which in turn stimulates the adrenal glands to both grow and release excessive amounts of cortisol in the blood. This causes a set of symptoms including weight gain (particularly in the face and neck), easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones and high blood pressure. Cushing’s disease is estimated to affect approximately 0.4 in 10,000 people in the European Union. This is equivalent to a total of around 20,000 people.