Regulators in the USA has approved a long-acting release of Novartis' Signifor as a treatment for acromegaly.

The Food and Drug Administration has approved Signifor LAR (pasireotide) for the treatment of patients with acromegaly who have had an inadequate response to surgery or for whom the latter is not an option. The thumbs-up comes a month after the European Medicines Agency approved the drug, a next-generation somatostatin analogue administered intramuscularly once-monthly.

Acromegaly is a rare, debilitating endocrine disorder caused by the excess production of growth hormone and insulin-like growth factor-1. In the majority of cases, the disease is caused by a non-cancerous tumour on the pituitary gland and is also associated with two- to three-fold increased mortality rates and serious health complications, including heart disease, hypertension, diabetes, arthritis and colon cancer.

Monica Gadelha of the Federal University of Rio de Janeiro said treating acromegaly “can be extremely challenging” and with the approval of Signifor LAR, “physicians now have a new therapy that provides an enhanced mechanism to address elevated hormone levels. This is a significant achievement”.

Novartis is hoping that Signifor LAR will eventually replace Sandostatin and Sandostatin LAR, which had third-quarter sales of $433 million, up 8%. Signifor was approved in 2012 as a twice-daily subcutaneous injection for Cushing's disease.