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Signifor long-acting release wins FDA approval for acromegaly treatment
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The FDA has approved a long-acting release formulation of pasireotide to treat patients with acromegaly who have either not responded to surgery or for whom surgery is not an option, according to statement from the drug developer.
Pasireotide long-acting release (LAR) (Signifor, Novartis), a next-generation somatostatin analog (SSA) designed for injectable suspension for intramuscular use, addresses an unmet need among patients with the endocrine disorder, according to the statement.
“Treating acromegaly can be extremely challenging and the consequences of inadequate normalization of hormone levels can be serious for patients,” Monica Gadelha, MD, PhD, of the Federal University of Rio de Janeiro, a pivotal trial study author, said in the statement.
“With the approval of Signifor LAR, physicians now have a new acromegaly therapy that provides an enhanced mechanism to address elevated hormone levels.”
The FDA approval is based on two multicenter randomized phase 3 studies that showed the effectiveness of pasireotide LAR in treating both medically naïve patients and those inadequately controlled on first-generation SSAs.
Higher rates of full biochemical control, defined as mean growth hormone (GH) level <2.5mcg/L and normal insulin-like growth factor-1 levels (IGF-1), were achieved with pasireotide LAR compared with a first-generation SSA in both studies.
Administered once monthly, pasireotide LAR binds to somatostatin receptors (SSTRs) and can stimulate both SSTR2 and SSTR5 subtype receptors, relevant for inhibition of GH and IGF-1 secretion.
In the United States, the therapy was given orphan drug designation for treatment of <200,000 patients, according to the statement. The European Medicines Agency approved pasireotide in November; Novartis submitted additional regulatory applications for pasireotide LAR worldwide.