Novartis’ Signifor recommended in Europe
pharmafile | January 20, 2012 | News story | Research and Development, Sales and Marketing | CHMP, Cushing's disease, Novartis, Signifor
A European committee has recommended Novartis’ Signifor for the treatment of a rare, debilitating endocrine disorder.
The European Committee for Medicinal Products for Human Use has recommended that Signifor (pasireotide) should be approved to treat Cushing’s disease, an endocrine disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumour.
The CHMP is recommending its use as a second-line treatment for patients who cannot have surgery, or for whom surgery has not been successful.
The final decision as to whether the drug should be approved now falls to the European Commission, which is expected to make its decision within the next three months.
There are currently no approved medicines in the European Union targeting Cushing’s disease, so the drug could be the first of its kind.
A number of medicines are being used off-label to treat the disease, but the available data on their safety and efficacy is limited.
The recommendation is based on clinical trials that showed Signifor reduced levels of cortisol in the urine, by around half in 41% of patients treated with a 900μg dose, and in 34% of patients treated with a lower 600μg dose.
The drug is injected twice-daily, but Novartis is currently undertaking a Phase III trial for a longer-acting form of the drug, that only requires injection once a month.
Cushing’s disease is a very rare, debilitating and life-threatening disease, where a small tumour of the pituitary (an endocrine gland) makes too much of the hormone adrenocorticotrophin, which in turn stimulates the adrenal glands to both grow and release excessive amounts of cortisol into 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.
The condition is very rare and affects around 20,000 people in the European Union; most of those affected are younger women, aged between 20 and 50 years of age.
Ben Adams
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