The US Food and Drug Administration (FDA) has approved Fensolvi (leuprolide acetate) to treat children, two years of age and older, with central precocious puberty.

Central precocious puberty is a rare endocrine disorder defined as the onset of puberty before the age of eight years in girls and nine years in boys.

Leuprolide acetate has long been used to treat this rare condition but the new formulation always the drug to be injected subcutaneously once every 6 months.

The approval was largely based on results from a multicenter, open-label, single arm Phase 3 study evaluating the efficacy, safety and pharmacokinetics of leuprolide acetate (45 mg in a 0.365 ml suspension) in 64 children with central (gonadotropin-dependent) precocious puberty. At the end of the study, 87% of children achieving a serum luteinizing hormone concentration of <4 IU/L at six months post injection. The study also demonstrated that the drug suppressed sex hormones to pre-pubertal levels, and stopped or reversed the progression of clinical signs of puberty.

In a news release, Karen Klein, MD, Associate Clinical Professor, Rady Children’s Hospital, University of California San Diego said,  “Children with CPP (central precocious puberty) 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. “Dr, Klein added, “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.”

The most common adverse events were injection site pain (31%), nasopharyngitis (22%), and fever (17%).

Leuprolide acetate is a gonadotropin releasing hormone (GnRH) agonist. GnRH-dependent central precocious puberty is the premature development of sexual maturation that sometimes occurs in girls younger than eight years and boys younger than nine years.

For more information about this and other endocrine disorders, go to our endocrine disorder page.


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