FDA Approves Leuprolide Acetate for Patients with Central Precocious Puberty

The U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for leuprolide acetate injectable suspension for the treatment of pediatric patients ≥2 years old with central precocious puberty (CPP).

Approval was based on results from a multicenter, open-label, single arm Phase 3 study including 64 children with CPP. Patients were treated with 45 mg of leuprolide acetate injectable suspension. At 6 months post-injection, 87% of patients achieved serum luteinizing hormone concentration of <4 IU/L. The treatment also 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,” said Karen Klein, MD, Associate Clinical Professor, Rady Children’s Hospital, University of California San Diego in a press release. “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.”

Read the full press release here.