Novartis gains US FDA approval of Signifor for acromegaly

The US Food and Drug Administration (FDA) has approved Swiss pharma giant Novartis’ (NOVN: VX) Signifor (pasireotide) long-acting release (LAR) 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, says Novartis, whose shares nevertheless dipped 0.9% to 87.85 Swiss francs in mid-morning trading.

"Treating acromegaly can be extremely challenging and the consequences of inadequate normalization of hormone levels can be serious for patients," said Monica Gadelha, Professor, Federal University of Rio de Janeiro, Brazil, and pivotal trial study author. "With the approval of Signifor LAR, physicians now have a new acromegaly therapy that provides an enhanced mechanism to address elevated hormone levels. This is a significant achievement and much welcomed news for patients with acromegaly," noted Dr Gadelha.