Leuprolide Acetate Granted FDA Approval for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

CPP is a rare disease defined as the onset of puberty before age 8 years in girls and before age 9 years in boys.

Officials with the FDA have approved a New Drug Application for leuprolide acetate (Fensolvi, Tolmar Pharmaceuticals). The drug is indicated for injectable suspension for the treatment of pediatric patients aged 2 years and older with central precocious puberty (CPP).

CPP is a rare disease defined as the onset of puberty before age 8 years in girls and before age 9 years in boys.

Known as the most widely used treatment for CPP, according to Tolmar, leuprolide acetate uses an innovative proprietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. The polymeric gel technology enables a small volume of injection of only 0.375mL, subcutaneous administration, and a 6-month dosing cycle.

The FDA’s approval was based on results from a phase 3 study evaluating the efficacy, safety, and pharmacokinetics of leuprolide acetate 45 mg for injectable suspension in 64 children with CPP. The study achieved its primary endpoint with 87% of children achieving a serum luteinizing hormone concentration of <4 IU/L at six months post injection.

In addition, the study demonstrated that leuprolide acetate suppressed sex hormones to pre-pubertal levels, and stopped or reversed the progression of clinical signs of puberty, according to Tolmar.

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%).

REFERENCE

FDA Approves FENSOLVI® (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty [news release]. Buffalo Grove, Ill.; PR Newswire: May 4, 2020. https://prnmedia.prnewswire.com/news-releases/fda-approves-fensolvi-leuprolide-acetate-for-injectable-suspension-for-pediatric-patients-with-central-precocious-puberty-301051621.html. Accessed May 4, 2020.