Acromegaly Support Group
Acromegaly (from Greek akros "high" and megas "large" - extremities enlargement) is a hormonal disorder that results when the pituitary gland produces excess growth hormone (hGH). Acromegaly most commonly affects middle-aged adults and can result in serious illness and premature death. Join the group to discuss symptoms, diagnosis, and treatments.
Does anyone have any more info on this?
Novartis gains FDA approval for Signifor LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder.
Basel, December 16, 2014 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Signifor long-acting release (LAR)* (pasireotide) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. The approval of Signifor LAR, a next-generation somatostatin analog (SSA), helps address a critical unmet need among the acromegaly patient population. Signifor LAR has been studied and found effective in both medically nave patients with acromegaly who have had prior surgery or for whom surgery was not an option, as well as patients whose disease is not fully controlled on first generation SSAs[2].
This FDA approval was based on two multicenter Phase III studies, C2305 and C2402, which respectively examined medically nave patients who have had prior surgery or for whom surgery was not an option and patients with acromegaly inadequately controlled on first generation SSAs. In both studies, higher rates of full biochemical control (defined as mean GH level
Novartis gains FDA approval for Signifor LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder.
Basel, December 16, 2014 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Signifor long-acting release (LAR)* (pasireotide) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. The approval of Signifor LAR, a next-generation somatostatin analog (SSA), helps address a critical unmet need among the acromegaly patient population. Signifor LAR has been studied and found effective in both medically nave patients with acromegaly who have had prior surgery or for whom surgery was not an option, as well as patients whose disease is not fully controlled on first generation SSAs[2].
This FDA approval was based on two multicenter Phase III studies, C2305 and C2402, which respectively examined medically nave patients who have had prior surgery or for whom surgery was not an option and patients with acromegaly inadequately controlled on first generation SSAs. In both studies, higher rates of full biochemical control (defined as mean GH level
This study evaluated pasireotide LAR 40 mg and 60 mg against continued therapy with octreotide LAR or lanreotide Autogel in patients who did not achieve GH and IGF-1 biochemical control despite receiving the maximum approved doses of these currently available somatostatin analogues (SSAs). In the trial, significantly more patients achieved biochemical control with each dose of pasireotide LAR compared to the octreotide LAR and lanreotide Autogel control arm. Specifically, 15.4% and 20.0% of those with inadequately controlled acromegaly taking pasireotide LAR 40 mg and 60 mg, respectively (95% confidence interval [CI], 7.6-26.5; P=0.0006; 95% CI, 11.1-31.8; P
Pasireotide is a sort ot newer genration spin on the sandostatin. The makers claim that it binds to more cell receptors and therefore is more effective.
My doctor was very skeptical that it is any better than sandostatin or lanreotide.
Ledgy