European Commission approves Novartis’ Signifor to treat patients with acromegaly

Acromegaly is a syndrome that results when the anterior pituitary gland produces excess growth hormone (GH) after epiphyseal plate closure at puberty.

Novartis Oncology president Bruno Strigini 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 European approval is based on data from two multicenter Phase III trials, C2402 and C2305, which evaluated patients with inadequately controlled acromegaly on first-generation SSAs, and medically naive patients who were post-surgery, or newly diagnosed patients for whom surgery is contraindicated.

The drug is indicated to acromegaly patients 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).

The next-generation SSA Signifor provides the first alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs.

Data from these trials showed Signifor to have superior efficacy in providing biochemical control, as measured by both GH and insulin-like growth factor-1 (IGF-1) levels, compared to a first-generation SSA.

Image: Novartis’ Signifor is indicated as a new long acting release formulation for once monthly intramuscular injection to treat adults with acromegaly. Photo: courtesy of Andrew.