Novartis loves and fears EMA
Basel – Good and bad news for Swiss drugmaker Novartis. First a look on the bright side: Signifor, for the treatment of Cushing's disease, is on its final stretch to approval. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the multi-receptor targeting somatostatin. "We are now one step closer to being able to offer patients in Europe the first approved medical treatment for Cushing´s disease", said Hervé Hoppenot of Novartis Oncology. Cushing´s syndrome is an endocrine disorder caused by excessive cortisol. Cushing´s disease is rare (one to two patients per million) but may result in weight gain, moon face, severe fatigue and weakness. But EMA has had bad tidings for The Swiss also: The agency said it started a review of Gilenya, its compound for multiple sclerosis. There are rumours that the drug could be connected to 11 deaths among patients that received treatment. These include seven unexplained deaths, three heart attacks and one due to disruption of heart rhythm. Up to now Gilenya's role in these incidents is not clear, the ageny said.