Novartis Reports Superior Efficacy Results For Acromegaly Drug
Novartis announced positive results from a pivotal Phase III trial of its investigational therapy Signifor LAR (pasireotide LAR; SOM230) in patients with acromegaly who have not been able to treat the disease with standard treatment. The data from the trial were presented at the 16th European Congress of Endocrinology.
Study findings show that patients taking pasireotide long-acting release (LAR) experienced greater disease control versus ongoing treatment with standard somatostatin analogue therapies octreotide LAR or lanreotide Autogel. With each dose of pasireotide LAR, more patients achieved biochemical control compared to the trial arms using somatostatin analogue therapies.
Alessandro Riva, president, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs, said, “These results strengthen our understanding of this rare endocrine disorder and suggest pasireotide LAR may offer benefit for acromegaly patients whose disease is not fully controlled on their current therapy.” Mr. Riva said that the company is committed to bring the potentially meaningful solution to rare pituitary diseases and especially to the acromegaly community.
Acromegaly results from a benign tumor within the pituitary gland that secretes excess growth hormone, causing spiked levels of insulin-like growth factor-1 (IGF-1). The combined effects of these two growth hormones cause enlargement of body parts such as facial features, hands, and feet. Acromegaly can also cause cardiovascular, respiratory, and metabolic diseases. Acromegaly patients have a two- to three-fold risk of death. Biochemical control of the disease is the primary goal of acromegaly treatment.
Dr. Monica Gadelha, professor at Federal University of Rio de Janeiro and author of the study, said, “Historically, we have evaluated somatostatin analogues for the treatment of acromegaly by the decrease in either growth hormone or insulin-like growth factor levels. With more sensitive assays and more stringent evaluation criteria, a recent meta-analysis indicates that up to 45 percent of patients can have either GH or IGF-I still elevated. As the health risks associated with acromegaly may persist until both GH and IGF-1 levels are normalized, this study further supports the importance of monitoring for and achieving full biochemical control.”
The company said that regulatory filings for pasireotide LAR in acromegaly are currently underway in different countries around the world. The regulatory submissions are based on trial results and separately published Phase III trial data.