Novartis receives CHMP recommendation for Signifor in acromegaly

Novartis has announced that its Signifor long-acting release (LAR) formulation has been recommended for European approval for treating a rare hormonal disorder.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has endorsed the drug for use in the treatment of 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 (SSA).

Data from two phase III trials has demonstrated the superior efficacy the therapy can offer in providing biochemical control compared to treatments with SSAs.

Acromegaly is an endocrine disorder caused by elevated growth hormone and insulin-like growth factor-1 levels. It can result in the enlargement of hands, feet, facial features and internal organs, creating serious health consequences.

Dr 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."

This comes after the company reported positive data from a phase III study of its drug Afinitor, showing its efficacy in the treatment of pancreatic neuroendocrine tumours.