Swiss drugmaker Novartis has received approval from US Food and Drug Administration (FDA) for its Signifor long-acting release LAR (pasireotide) for injectable suspension and intramuscular use to treat patients with acromegaly.
Signifor LAR is designed for patients with acromegaly who had an inadequate response to surgery or for whom surgery is not an option.
Signifor LAR is a somatostatin analogue (SSA) administered intramuscularly once a month, which exerts its pharmacological activity through binding to somatostatin receptors (SSTRs).
Acromegaly is a rare and debilitating endocrine disorder caused by excess production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1).
Federal University of Rio de Janeiro professor and pivotal trial study author Dr Monica Gadelha said: "Treating acromegaly can be extremely challenging and the consequences of inadequate normalisation of hormone levels can be serious for patients."
The approval was based on two multicentre Phase III trials, C2305 and C2402, which examined medically naive patients who had prior surgery or for whom surgery was not an option, and patients with acromegaly inadequately controlled on first generation SSAs.
The company noted higher rates of full biochemical control were achieved with Signifor LAR, compared to a first generation SSA in both trials.
Novartis Oncology president Bruno Strigini said: "The FDA approval of Signifor LAR for acromegaly marks an important day for physicians and patients living with difficult-to-treat pituitary conditions and underscores our continued commitment to helping patients manage rare diseases."
Signifor LAR received orphan drug designation for acromegaly in the US. The European Medicines Agency (EMA) approved Signifor to treat adult patients with acromegaly for whom surgery is not an option or was not curative, and who are inadequately controlled on treatment with a first-generation SSA.
Image: The hand of a patient with acromegaly (right) is enlarged, the fingers widened, thickened and stubby, and the soft tissue thickened, compared to the hand of an unaffected person (left). Photo: courtesy of Philippe Chanson and Sylvie Salenave.