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.