Novartis Drug Signifor Approved in EU, Marking an Advance for Patients with Inadequately Controlled Acromegaly

The European Commission has approved Novartis's 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 tumour 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.

"Acromegaly that is not properly controlled can have a devastating impact on the long-term health of patients living with this serious pituitary disorder," said Bruno Strigini, President, Novartis Oncology. "This first approval of Signifor in acromegaly marks a much needed advance in the treatment of this rare disease and we are working hard to bring this therapy to this underserved patient population worldwide in the near future."

The approval is based on data from two multicenter Phase III studies, C2402 and C2305, which respectively evaluated patients with inadequately controlled acromegaly on first-generation SSAs, and medically naïve patients who were post-surgery, or newly diagnosed patients for whom surgery is contraindicated. Both studies showed Signifor to have superior efficacy in providing biochemical control, as measured by both GH and IGF-1 levels, compared to a first-generation SSA.

The EU approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in September 2014 for Signifor for the treatment of acromegaly and applies to all 27 EU member states, plus Iceland and Norway. Additional regulatory applications for the new long acting release formulation of Signifor have been filed worldwide for the treatment of acromegaly, including an application currently filed in the US. In the EU, Signifor has orphan drug designation for acromegaly.