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Home Industry News Novartis’ Signifor recommended for Cushing’s disease by CHMP

Novartis’ Signifor recommended for Cushing’s disease by CHMP

23rd January 2012

Novartis' new drug Signifor has been recommended for approval by the European Medicines Agency as a therapy option for Cushing's disease.

The agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the pasireotide-based therapy, following encouraging data from the landmark phase III trial Pasport-Cushings.

Signifor has orphan drug designation for Cushing's disease, a rare but serious endocrine disorder in which the presence of a non-cancerous pituitary tumour causes excess cortisol production in the body.

It affects around five in every 10,000 people in the EU, with women aged between 20 and 50 noted as being at the greatest risk.

Herve Hoppenot, president of Novartis Oncology, said: "We are now one step closer to being able to offer patients in Europe the first approved medical treatment for Cushing's disease."

Last week, the company received a recommendation from the UK's National Institute for Health and Clinical Excellence for its chronic myeloid leukaemia therapy Tasigna to be made available to NHS patients.ADNFCR-8000103-ID-801271482-ADNFCR

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