Leuprolide for central precocious pubertyJune 10, 2020
The US FDA has approved leuprolide acetate (Fensolvi) injectable suspension for treating children aged 2 years and older with central precocious puberty.
The drug is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two years of age and older with central precocious puberty. CPP is a rare disease characterised by the onset of puberty before age eight in girls and before age nine in boys.
Leuprolide acetate is the most widely used treatment for CPP. It utilises an innovative proprietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. This polymeric gel technology enables a small volume of injection of only 0.375mL, subcutaneous administration, and a six-month dosing cycle.