Abbott two new strengths of CPP drug gets FDA nod

Abbott has received the US Food and Drug Administration (FDA) approval for two new strengths of Lupron Depot-PED (leuprolide acetate for depot suspension) to treat children with central precocious puberty (CPP). The application was submitted to FDA on the basis of results from a 24-week study assessing 84 patients with central precocious puberty.In the trial, the enrolled patients were given a total of two injections, 12 weeks apart, and were followed for nearly six months to investigate hormone suppression and safety.

The trial results suggested that hormone suppression with the new three-month depot formulation in both strengths was sustained in patients throughout the treatment period.Abbott Global Pharmaceutical Development vice president Eugene Sun said the approval of two new three-month depot strengths of Lupron Depot-PED is important because it adds additional treatment options for children with CPP and may reduce the number of injections per year from 12 to four.