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news.Novartis has reported positive results from Phase III study which showed that Pasireotide (SOM230) long-acting release (LAR) was effective at inducing full biochemical control compared to Sandostatin LAR (octreotide/IM injection).
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With significantly more patients treated with pasireotide LAR (31.3%) experiencing full control of their disease than those taking octreotide LAR (19.2%) (p=0.007), the study met its primary endpoint.
Novartis Oncology president Herve Hoppenot said the positive results seen in the Phase III trial point to the potential role of Pasireotide LAR in treating patients with acromegaly, a condition for which there remains an unmet need.
The Phase III PASireotide clinical trial PORTfolio, ACROMEGALY (PASPORT-ACROMEGALY) is a randomized double-blind study assessing the efficacy and safety of pasireotide LAR in 358 patients with active acromegaly.
In the study, patients were randomized to receive intramuscular injections of Pasireotide LAR 40mg or octreotide LAR 20mg every 28 days for 12 months.
Pasireotide is an investigational multireceptor targeting somatostatin analog that is approved in the EU as signifor for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.