The U.S. Food and Drug Administration (FDA) last month approved leuprolide acetate for injectable suspension for the treatment of pediatric patients two years of age and older with central precocious puberty (CPP). Tolmar Pharmaceuticals is marketing the drug as Fensolvi.
Leuprolide acetate is the most widely used treatment for CPP. Fensolvi utilizes a proprietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. This technology enables a small volume of injection of only 0.375mL, subcutaneous administration, and a six-month dosing cycle.
FDA approval was based on results from a multicenter, open-label, single arm Phase 3 study evaluating the efficacy, safety and pharmacokinetics of leuprolide acetate (LA) 45 mg for injectable suspension in 64 children with central (gonadotropin-dependent) precocious puberty. The study achieved its primary endpoint, with 87 percent of children achieving a serum luteinizing hormone concentration of <4 IU/L at six months post injection. The study also demonstrated that Fensolvi suppressed sex hormones to pre-pubertal levels, and stopped or reversed the progression of clinical signs of puberty.
“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,” says Endocrine Society member Karen Klein, MD, associate clinical professor at the University of California San Diego. “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.”
Treatment emergent adverse events (TEAEs) were mostly mild or moderate, with none leading to withdrawal from the study. The most common TEAEs were injection site pain (31%), nasopharyngitis (22%), and fever (17%).