Novartis has been given the go-ahead in the EU to sell a new long-acting formulation of its Signifor for patients with the rare growth disorder acromegaly.
Signifor (pasireotide) was first approved in Europe in 2012 as a twice-daily subcutaneous injection for Cushing’s disease, but the new depot formulation – called Signifor LAR – requires just one intramuscular injection a month.
Acromegaly is caused by a non-cancerous tumour in the pituitary gland that causes excessive secretion of growth hormone (GH), which in turn leads to elevated levels of insulin-like growth factor-1 (IGF-1).
The result is that the bones of patients with the disorder increase in size, particularly those in the hands, feet and face, alongside other complications such as diabetes, arthritis, kidney disease and cancer.
Approval for acromegaly comes on the back of two large phase III trials showing superior efficacy for Signifor LAR compared to other somatostatin analogues (SSAs) such as Novartis’ own octreotide depot Sandostatin LAR and Ipsen’s Somatuline Autogel (lanreotide).
Both studies showed Signifor to have superior efficacy in providing biochemical control, as measured by both GH and IGF-1 levels, compared to a first-generation SSA.
“Acromegaly that is not properly controlled can have a devastating impact on the long-term health of patients living with this serious pituitary disorder,” commented Bruno Strigini, president of Novartis’ oncology division that is responsible for selling the product.
“This first approval of Signifor in acromegaly marks a much needed advance in the treatment of this rare disease.”
Novartis wants Signifor LAR as a replacement for Sandostatin LAR, which was its fifth-largest product last year with sales of $1.59bn, but has now lost patent protection in most major world markets.
At the moment the product is bearing up well – sales in the first nine months of the year grew 5% to $1.23bn thanks to the roll-out of an improved delivery device – but eventually generic competition is expected to take its toll.
Signifor LAR has been submitted worldwide for the treatment of acromegaly, with an application filed in the US earlier this year, said Novartis. It is also testing the new formulation for Cushing’s disease and expects it to be submitted for this indication sometime in 2015.