Novartis International AG (NVS) Monday said results from a late-stage study showed its novel therapy pasireotide LAR (long-acting release) to be more effective than the current standard medical therapy in patients with acromegaly - a rare hormonal disorder. The study met its primary endpoint.
According to the Swiss drugmaker, pasireotide LAR induced full biochemical control compared to the standard of care Sandostatin LAR.
Acromegaly, caused by excess growth hormone, is characterized by enlargement of hands, feet and internal organs, as well as changes in facial structure.
Sandostatin LAR is a long-acting, injectable depot formulation of octreotide acetate. The study, named pasport-acromegaly, is a randomized, double-blind, Phase III study evaluating the efficacy and safety of pasireotide LAR, compared to octreotide LAR, in 358 patients with active acromegaly.
Hervé Hoppenot, president, Novartis Oncology 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. These findings are welcome news as we continue our research efforts to discover treatments for patients with pituitary-related conditions."
Patients treated with pasireotide LAR were 63 percent more likely to achieve full biochemical control than those on Sandostatin LAR. The safety profile of pasireotide LAR was similar to that of octreotide LAR, except a higher degree of hyperglycemia. Most adverse events were mild or moderate, the company said.
NVS closed Friday's regular trading at $54.1 on the NYSE.
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