Tolmar’s Fensolvi Received the US FDA’s Approval to Treat Pediatric Patients Two Years of Age and Older with Central Precocious Puberty (CPP)

Shots:

• The approval is based on P-III study which involves assessing of leuprolide acetate (LA,45 mg) in 64 children with central (gonadotropin-dependent) precocious puberty evaluating its safety and pharmacokinetics
• The study achieved its 1E i.e. 87% of children achieved a serum luteinizing hormone concentration of <4 IU/L at six months post injection with most common TEAEs were injection site pain (31%), nasopharyngitis (22%), and fever (17%)
• Fensolvi (leuprolide acetate) is a novel six-month, subcutaneous leuprolide acetate an gonadotropin releasing hormone (GnRH) agonist with small injectable suspension pproved for the treatment of pediatric patients two years of age and older with Central Precocious Puberty

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