Novartis’ Signifor approved in Europe as acromegaly treatment

Novartis has announced that its drug Signifor has been approved in Europe as a treatment for acromegaly, a rare pituitary disorder.

A new long-acting release Signifor formulation has been approved for once-monthly intramuscular injection in 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.

It represents the first alternative treatment option directly targeting the pituitary tumour for patients who have not responded to current therapies. The approval was based on positive safety and efficacy data from two large phase III trials.

Additional regulatory filings of this new long-acting release formulation of Signifor are currently under review by health authorities worldwide.

Bruno Strigini, president of Novartis Oncology, said: "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."

This comes after the company's new psoriasis therapy Cosentyx was recommended for European approval by the Committee for Medicinal Products for Human Use earlier this week.