Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Novartis has obtained approval from the US Food and Drug Administration for its Signifor long-acting release (LAR) (pasireotide) for injectable suspension, for intramuscular use, to treat patients with acromegaly.
Subscribe to our email newsletter
Signifor LAR is a somatostatin analog (SSA) administered intramuscularly once-monthly, which exerts its pharmacological activity through binding to somatostatin receptors (SSTRs).
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.
"We are pleased that a new treatment option is now available to help address the serious impact of uncontrolled acromegaly, and are optimistic about providing this much needed treatment to other patients worldwide in the near future."
The approval was based on two multicenter Phase III trials, C2305 and C2402, which examined medically naïve patients who have had prior surgery or for whom surgery was not an option and patients with acromegaly inadequately controlled on first generation SSAs.
The company said that higher rates of full biochemical control were achieved with Signifor LAR compared to a first generation SSA, in both trials.
Signifor LAR has 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 has not been curative and who are inadequately controlled on treatment with a first-generation SSA.
The company also submitted additional regulatory applications for Signifor LAR across the globe.
Image: The decision on EU approval of this heart failure medicine LCZ696 is expected within 2015. Photo: courtesy of Andrew.