FDA Approves Leuprolide Acetate for Central Precocious Puber
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for leuprolide acetate (FENSOLVI) injectable suspension for the treatment of pediatric patients ≥2 years old with central precocious puberty (CPP).

CPP, a rare disease defined by puberty onset prior to age 8 in girls and age 9 in boys, drives patient risk of significantly short stature as adults as well as issues in social, psychological, and emotional settings. The one in 5000-10,000 children who develop CPP are prone to lower self-esteem, stress, anxiety, and depression. The leuprolide acetate injection—among the most common therapies for CPP—is a 45 mg therapy dosed every 6 months.

The trial achieved its primary endpoint, with 87% of children achieving a serum luteinizing hormone concentration of <4 IU/L at 6 months post-injection. Treated patients also demonstrated suppressed sex hormones at pre-pubertal levels, as well as stopped or even reversed progression of clinical signs of puberty.

Mild to moderate treatment emergent adverse events included injection site pain (31%), nasopharyngitis (22%), and fever (17%). Clinicians praised the therapy’s shown clinical benefits, as well as the approval of another option in treating CPP.

Source: https://www.mdmag.com/medical-news/fda-approves-leuprolide-acetate-central-precocious-puberty