Novartis reports efficacy of Signifor LAR for acromegaly after Phase III trial

Acromegaly, a condition often linked with gigantism, occurs when the pituitary gland produces too much growth hormone (GH) after puberty leading to abnormal and excessive growth of the feet, hands and face.

Besides causing physical disfigurement, acromegaly, which often develops as a result of a tumor growing in the pituitary gland, can cause health complications and even premature death when left untreated. Health issues associated with the condition include diabetes, arthritis, colorectal cancer, diabetes, kidney failure, hypertension and heart disease.

Several treatments are already available for patients suffering from the condition but a new option for treating acromegaly sufferers may be available soon as Swiss pharmaceutical company Novartis announced positive results of the Phase III trial of its Signifor long-acting release (LAR) therapy.

The randomized, double-blind Phase III trial, which involved 198 patients, assessed the effects of pasireotide LAR 40 mg and pasireotide LAR 60 mg as compared with octreotide LAR 30 mg or lanreotide Autogel 120 mg.

Novartis announced on Monday that the outcome of the final-stage trial, which was presented at the 16th European Congress of Endocrinology in Poland, showed that patients on pasireotide LAR exhibited better disease control as measured by levels of GH and insulin-like growth factor-1 (IGF-1 ) when compared with patients who received the standard somatostatin analogue therapies octreotide LAR and lanreotide Autogel.

"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," said global head of development and medical affairs of Novartis Oncology Alessandro Riva.

Acromegaly, a rare condition which occurs in only about five per 100,000 per year, more often strikes in middle age. Because of the slow progression of the disease, it can be hard to diagnose in its early stages and only often becomes evident when changes in the physical features of the sufferer become noticeable.

Notable figures known to have suffered from the condition include U.S. 16th president Abraham Lincoln, wrestler André René Roussimoff more popularly known as André the Giant, The Addams Family TV series actor Ted Cassidyand Roman Emperor Maximinus I.

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