EC Approves Novartis' Signifor For Acromegaly In EU
Novartis announced that it has received the approval of the European Commission for Signifor (pasireotide) as treatment for adult patients with acromegaly in the EU.
The EC approved Signifor as a new, long acting release formulation for intramuscular injection once monthly for the treatment of acromegaly patients who are not qualified for surgery and whose disease is inadequately controlled by a first-generation somatostatin analogue (SSA). The next-generation SSA Signifor targets the pituitary tumor which is the culprit behind acromegaly.
Acromegaly is a rare, disabling disease caused by the uncontrolled production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). The disease typically results from a benign tumor that affects the pituitary gland. Acromegaly is marked by extreme physical changes, enlarged hands, feet, internal organs, and facial features. Exposure to excessive levels of GH and IGF-1 may result in heart disease, diabetes, and increased mortality risk. Around 1 to 2 people per 10,000 are affected by acromegaly in the EU.
Bruno Strigini, President of Novartis Oncology, said, “Acromegaly that is not properly controlled can have a devastating impact on the long-term health of patients living with this serious pituitary disorder. 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 EC’s decision was based on positive results from two Phase 3 studies investigating the drug in patients with inadequately controlled acromegaly; treatment-naïve, post-surgery patients; or newly diagnosed patients who are unable to undergo surgery. Results show that Signifor demonstrated superior efficacy compared to a first-generation SSA in providing biochemical control for GH and IGF-1 levels.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Signifor as treatment for acromegaly in the EU early in October.