FDA approves twice-yearly leuprolide injection for central precocious puberty
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A leuprolide acetate suspension to be dosed every 6 months has been approved by the FDA for use in treating children aged at least 2 years with central precocious puberty, according to a press release from Tolmar Pharmaceuticals.
The drug, Fensolvi, is a gonadotropin-releasing hormone agonist in a polymeric gel form. After subcutaneous injection of 0.375 mL, the gel becomes a solid that remains under the skin and releases leuprolide over time. The small volume and extended release allow for greater flexibility in choosing injection sites and for fewer injections — every 6 months rather than monthly or every 3 months, according to the release.
Fensolvi was evaluated in an open-label, single arm phase III trial with 64 children with gonadotropindependent precocious puberty. The primary endpoint, a serum luteinizing hormone level of less than 4 IU/L at 6 months, was reached by 87% of participants.
Central precocious puberty is sexual development in girls younger than 8 years old and boys younger than 9 years old.
“Children with 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,” Karen Klein, MD, associate clinical professor at Rady Children’s Hospital, University of California San Diego, said in the release. “Fensolvi offers treating physicians and their patients with central precocious puberty a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance.”
As Healio previously reported, recent legislation designed to deny therapy with pubertal blockers such as leuprolide to transgender youths may threaten their use for children with central precocious puberty. – by Jill Rollet
Disclosure: Healio could not confirm relevant financial disclosures at the time of publication.