The Food and Drug Administration (FDA) has approved Fensolvi (leuprolide acetate; Tolmar Pharmaceuticals) for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
The active ingredient of Fensolvi is leuprolide acetate, a gonadotropin releasing hormone (GnRH) agonist. Through proprietary polymeric gel technology, the drug is released in a sustained and controlled manner over time and also allows for a smaller volume of injection. Fensolvi is administered as a subcutaneous injection every 6 months by a healthcare professional.
The approval was based on data from an open-label, single arm phase 3 study that evaluated the safety, efficacy, and pharmacokinetics of Fensolvi in 64 children with central precocious puberty. Patients (mean age: 7.5 years) received Fensolvi 45mg subcutaneously at 6 month intervals for the 12 month study period. The primary end point of the study was the percentage of patients with suppression of peak-stimulated luteinizing hormone (<4 IU/mL) at 6 months.
Results showed that suppression of peak stimulated luteinizing hormone concentrations to <4 IU/L was achieved in 87% of pediatric patients by month 6 and in 86% of patients by month 12. Moreover, suppression of estradiol or testosterone concentration to prepubertal levels at 6 months was achieved in 97% and 100% of patients. At 12 months, 98% of females and 50% of males maintained suppression.
Additionally, the study demonstrated that treatment with Fensolvi arrested or reversed progression of clinical signs of puberty with reductions in growth velocity and bone age.
With regard to safety, the most common adverse reactions reported included injection site pain and erythema, nasopharyngitis, pyrexia, headache, cough, abdominal pain, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush.
Fensolvi is supplied in a kit containing a single-dose prefilled syringe with 45mg of lyophilized leuprolide acetate powder, as well as a syringe with diluent for reconstitution. It is expected to be available in late May 2020.
For more information visit fensolvi.com.