Fensolvi Approved for Central Precocious Puberty

May 4, 2020 – The U.S. FDA has approved Fensolvi® (leuprolide acetate), manufactured by Tolmar Pharmaceuticals, to treat pediatric patients two years of age and older who have central precocious puberty. Fensolvi uses a proprietary polymeric gel technology to form a solid after injection that releases leuprolide acetate – a current standard of care for CPP – in a sustained and controlled manner over time.

Central precocious puberty (CPP) occurs when children experience premature development of the signs of sexual maturation. For female children, these signs should not occur before the age of eight. For male children, they should not occur before age nine. CPP can have negative effects on an individual’s physical growth as well as social, psychological, and emotional development. Individuals who have CPP may experience anxiety, depression, and low self-esteem.

In a clinical study, 87% percent of children treated with Fensolvi achieved a serum luteinizing hormone concentration of < 4 IU/L at six months post injection. Luteinizing hormone helps control the reproductive systems of females and males and is used to screen for the presence of CPP in children. Fensolvi also suppressed sex hormones to pre-pubertal levels and stopped or reversed the progression of clinical signs of puberty.

Recommended dosing is 45mg administered by subcutaneous injection once every six months. Treatment should be discontinued at an appropriate age for puberty onset. The patient’s response should be monitored to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics. In addition, the patient’s height should be measured every three to six months, and their bone age should be measured periodically.

Tolmar has launched Fensolvi at a wholesale acquisition cost (WAC) of $22,578 per 45mg injection.