FDA Approves FENSOLVI for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

Tolmar Pharmaceuticals, Inc. recently announced the US FDA has approved its New Drug Application for FENSOLVI (leuprolide acetate) for injectable suspension for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). CPP is a rare disease defined as the onset of puberty before age eight in girls and before age nine in boys.

Leuprolide acetate is the most widely used treatment for CPP. Fensolvi utilizes 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. This polymeric gel technology enables a small volume of injection of only 0.375-mL, subcutaneous administration, and a 6-month dosing cycle.

“We are very enthusiastic about our clinical data demonstrating the efficacy and safety of Fensolvi. The 6-months dosing schedule, small volume of injection, and subcutaneous administration are important new product features,” said Dr. Stuart Atkinson, MB ChB, Vice President and Head of Medical Affairs, Tolmar Pharmaceuticals.

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% of children achieving a serum luteinizing hormone concentration of <4 IU/L at 6 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,” said Karen Klein, MD, Associate Clinical Professor, Rady Children’s Hospital, 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%).

 Gonadotropin-releasing hormone (GnRH)-dependent central precocious puberty (CPP) is the premature development of signs of sexual maturation occurring in girls younger than 8 and in boys younger than 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, all of which may negatively impact quality of life. CPP is believed to have a five- to twenty-fold higher incidence in girls than in boys and is estimated to occur in one in 5,000-10,000 children.

 Fensolvi (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients two years of age and older with CPP. It is a prescription drug, given by injection.

Fensolvi is the first and only 6-month, subcutaneous leuprolide acetate with a small injection volume that allows flexibility in selection of injection site and enables administration in an office setting.  Fensolvi represents an effective, safe and convenient treatment option for this vulnerable patient group, and its profile aligns with twice-yearly visits to the pediatric endocrinologist’s office.

Information about FENSOLVI is available at http://fensolvi.com

 Tolmar is a fully integrated pharmaceutical company focused on the innovative development, approval, manufacturing and commercialization of specialty pharmaceuticals. Tolmar refers to Tolmar Holding, Inc. and its wholly owned operating subsidiaries, Tolmar Inc., Tolmar Therapeutics, Inc., and Tolmar Pharmaceuticals, Inc. Tolmar global headquarters, product development and manufacturing facilities are based in northern Colorado, while Tolmar Pharmaceuticals’ US commercial business is based in Buffalo Grove, IL. For more information, visit www.tolmar.com.