FDA Approves Leuprolide Acetate for Central Precocious Puber
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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
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