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A long-acting formulation of the somatostatin analogue pasireotide has been approved for treatment of acromegaly in patients “who have had an inadequate response to surgery and/or for whom surgery is not an option,” the manufacturer, Novartis, has announced.
In a Dec. 16 statement, the company said that Food and Drug Administration approval was based on two phase III studies, one that enrolled medically naive patients with the rare endocrine disorder who had surgery previously or for whom surgery was not an option, and a study of patients who were not adequately controlled on treatment with other somatostatin analogues (SSAs). Treatment was effective in both populations, based on “higher rates of full biochemical control” (mean GH level under 2.5 mcg/L and normal IGF-1 levels) among those treated with long-acting pasireotide compared with the other SSA, according to Novartis.
The most common adverse events associated with treatment, affecting at least 20% of patients, were cholelithiasis, hyperglycemia, and diabetes, according to the prescribing information, which includes a warning about the risk of hyperglycemia and diabetes, bradycardia and QT prolongation, liver test elevations, and cholelithiasis.
A regular formulation of pasireotide was approved by the FDA in 2012, for the treatment of adults with Cushing’s disease “for whom pituitary surgery is not an option or has not been curative.” It is marketed as Signifor. The long-acting formulation, administered intramuscularly once a month, will be marketed as Signifor LAR . In November 2014, it was approved in Europe for the acromegaly indication, Novartis said.
A long-acting formulation of the somatostatin analogue pasireotide has been approved for treatment of acromegaly in patients “who have had an inadequate response to surgery and/or for whom surgery is not an option,” the manufacturer, Novartis, has announced.
In a Dec. 16 statement, the company said that Food and Drug Administration approval was based on two phase III studies, one that enrolled medically naive patients with the rare endocrine disorder who had surgery previously or for whom surgery was not an option, and a study of patients who were not adequately controlled on treatment with other somatostatin analogues (SSAs). Treatment was effective in both populations, based on “higher rates of full biochemical control” (mean GH level under 2.5 mcg/L and normal IGF-1 levels) among those treated with long-acting pasireotide compared with the other SSA, according to Novartis.
The most common adverse events associated with treatment, affecting at least 20% of patients, were cholelithiasis, hyperglycemia, and diabetes, according to the prescribing information, which includes a warning about the risk of hyperglycemia and diabetes, bradycardia and QT prolongation, liver test elevations, and cholelithiasis.
A regular formulation of pasireotide was approved by the FDA in 2012, for the treatment of adults with Cushing’s disease “for whom pituitary surgery is not an option or has not been curative.” It is marketed as Signifor. The long-acting formulation, administered intramuscularly once a month, will be marketed as Signifor LAR . In November 2014, it was approved in Europe for the acromegaly indication, Novartis said.
A long-acting formulation of the somatostatin analogue pasireotide has been approved for treatment of acromegaly in patients “who have had an inadequate response to surgery and/or for whom surgery is not an option,” the manufacturer, Novartis, has announced.
In a Dec. 16 statement, the company said that Food and Drug Administration approval was based on two phase III studies, one that enrolled medically naive patients with the rare endocrine disorder who had surgery previously or for whom surgery was not an option, and a study of patients who were not adequately controlled on treatment with other somatostatin analogues (SSAs). Treatment was effective in both populations, based on “higher rates of full biochemical control” (mean GH level under 2.5 mcg/L and normal IGF-1 levels) among those treated with long-acting pasireotide compared with the other SSA, according to Novartis.
The most common adverse events associated with treatment, affecting at least 20% of patients, were cholelithiasis, hyperglycemia, and diabetes, according to the prescribing information, which includes a warning about the risk of hyperglycemia and diabetes, bradycardia and QT prolongation, liver test elevations, and cholelithiasis.
A regular formulation of pasireotide was approved by the FDA in 2012, for the treatment of adults with Cushing’s disease “for whom pituitary surgery is not an option or has not been curative.” It is marketed as Signifor. The long-acting formulation, administered intramuscularly once a month, will be marketed as Signifor LAR . In November 2014, it was approved in Europe for the acromegaly indication, Novartis said.
