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November 24, 2014

European Commission grants approval for Novartis’s Signifor to treat acromegaly

Swiss drug-maker Novartis has received approval from European Commission for its Signifor (pasireotide) intramuscular injection to treat adult patients suffering from acromegaly.

Acromegaly

Swiss drug-maker Novartis has received approval from European Commission for its Signifor (pasireotide) intramuscular injection to treat adult patients suffering from acromegaly.

The approval was granted for Signifor as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly.

This is designed for people without the option of surgery or who have not been curative, and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA).

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 approval was granted for Signifor as a new long acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly. "

Approval was based on data from two multicentre Phase III trials, C2402 and C2305, which assessed 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.

Signifor proved its efficacy in providing biochemical control as measured by both growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels, compared against Sandostatin LAR or Somatuline Autogel, in both trials.

A long-acting and injectable depot formulation of octreotide acetate, Sandostatin LAR received approval in the European Union (EU) to treat patients with acromegaly in whom surgery is inappropriate or ineffective.

It can also be used in the interim period until radiotherapy becomes fully effective, under recently finalised label harmonisation.

Sandostatin LAR is available from Novartis for different uses, and is not available in all indications in every country.


Image: The hand of a patient with acromegaly (right) compared with the hand of an unaffected person (left). Photo: courtesy of Philippe Chanson and Sylvie Salenave.

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