Novartis announced today that the US Food and Drug Administration (FDA) has approved Signifor® long-acting release (LAR)* (pasireotide) a once-a-month version for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
The approval of Signifor LAR, a next-generation somatostatin analog (SSA), helps address a critical unmet need among the acromegaly patient population. Signifor LAR has been studied and found effective in both medically naïve patients with acromegaly who have had prior surgery or for whom surgery was not an option, as well as patients whose disease is not fully controlled on first generation SSAs.
With the approval, Signifor, already approved to treat Cushing’s disease in a twice-daily formulation, will take the mantle from Novartis’ own Sandostatin, a blockbuster injectable for acromegaly that came off patent in the U.S. this year. The disease is estimated to effect about 60 over every million people worldwide, Novartis said, but, due to difficulties in diagnosis, that number could be nearly 5 times greater.
But Novartis isn’t the only contender in the acromegaly field. Roche reached out to Chiasma in a $595 million deal last year to get its hands on a Phase III oral treatment for the disease, which the companies believe could disrupt the injectable-dominated market.