Novartis announced today that the European Commission has approved Signifor (pasireotide) as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA). Next-generation SSA Signifor offers the first alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs.

Acromegaly affects an estimated one to two in every 10,000 people in the EU. In the majority of acromegaly cases, a non-cancerous tumor in the pituitary gland leads to excess production of growth hormone (GH) and, ultimately, insulin-like growth factor-1 (IGF-1) in the body. Prolonged exposure to excess GH and IGF-1 may cause patients to experience significant physical changes including the enlargement of hands, feet, facial features, and internal organs. Moreover, acromegaly patients who do not achieve biochemical control of their disease, as measured by GH and IGF-1 levels, may face serious health consequences such as heart disease, hypertension, diabetes, arthritis, colon cancer leading to an increased risk of death. According to recent research, 45% of acromegaly patients fail to achieve the recommended levels of GH or normalized IGF-1 on current therapies.

For more details, go to: http://www.novartis.com/newsroom/media-releases/en/2014/1873488.shtml