The European Medicines Agency (EMA) has approved the Novartis drug Signifor as the first medication to treat Cushing’s disease.
Signifor has been approved for use in adult patients with Cushing’s disease, particularly for those for which surgery either is not a feasible option, or has failed.
The approval is based on data from the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease.
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Cushing’s disease is a very rare hormonal disorder which is caused when an underlying tumour on the pituitary gland triggers the production of excess cortisol.
As a result, this can cause weight gain and an increase in blood pressure, along with depression, anxiety, fatigue and weakness.
Signifor works by reducing the levels of cortisol in the patients’ bodies.
It was discovered that with reduced cortisol levels, key clinical manifestations of the disease improved, which included a reduction in blood pressure, cholesterol, weight and body mass index (BMI).
Commenting on the approval of Signifor, the President of Novartis Oncology, Hervé Hoppenot, said: “As the first therapeutic option to specifically target Cushing's disease, Signifor has the potential to redefine treatment of this debilitating disease.
“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 European Union.”
Meanwhile, Ellen van Veldhuizen, a board member of the Dutch Adrenal Society, added: “Patients with Cushing's disease often struggle with a variety of debilitating health issues associated with the overproduction of cortisol and previously were faced with a treatment approach limited to surgery.
“The approval of pasireotide as a new treatment option that may help patients with Cushing's disease is welcome news.”
Cushing’s disease is most common in adults aged between 20 and 50 years old and is three more times common in women than it is in men.
The EMA’s approval of Signifor is more welcome news for Novartis, which only last week had its treatment for multiple sclerosis, Gilenya, approved for continued use.
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