CHMP Recommends Novartis' Signifor For Acromegaly

Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the company’s Signifor (pasireotide) long-acting release (LAR) formulation as treatment for certain adult patients with acromegaly.

Signifor LAR is a next-generation somatostatin analogue (SSA) intended to treat patients with acromegaly who cannot undergo surgery or who have failed to be curative and whose disease has been inadequately controlled by first-generation SSAs. The company said that, if approved, Signifor could provide a new therapeutic option for about 45 percent of acromegaly patients who have inadequate responses to standard SSAs. Signifor LAR has been granted an Orphan Drug status in the EU for the treatment of acromegaly. The drug also received approval in 2012 as treatment for the endocrine disorder, Cushing’s disease.

Acromegaly is a rare, debilitating endocrine disorder resulting from the excessive production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). This is often caused by a benign tumor that is affecting the pituitary gland. Symptoms include extreme physical changes, including enlargement of facial features, hands, feet, and internal organs. Prolonged exposure to abnormal levels of GH and IGF-1 may also cause diabetes, heart disease, and an increased mortality risk. The disease affects an estimated one to two people per 10,000 in the EU.

Alessandro Riva, Global Head of Novartis Oncology Development and Medical Affairs, said, “This positive CHMP opinion for Signifor LAR formulation represents a significant step towards our goal of being able to offer adult patients with inadequately controlled acromegaly in the EU a much-needed alternative treatment option.”

The positive opinion of the CHMP is based on results from two multicenter Phase 3 studies, C2402 and C2305. Findings show that Signifor LAR demonstrated greater efficacy in biochemical control as measured by growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels versus a first generation SSA. Novartis published the studies’ results in The Lancet Diabetes & Endocrinology journal.

Novartis stated that it is currently filing global regulatory submissions for Signifor LAR in acromegaly, while further applications are undergoing review by health officials.