Wikimedia Commons/FitzColinGerald/ Creative Commons License
Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.
Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).
“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.