FDA approves two new strengths of Lupron Depot-PED for central precocious puberty

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved two new strengths for three-month administration of Lupron Depot-PED ® (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP).  CPP is a condition that causes children to enter puberty too soon, resulting in the development and progression of secondary sex characteristics such as breast development in females and genital development in both males and females, and can potentially lead to a diminished adult height.  By definition, CPP starts in girls under the age of 8 and boys under the age of 9.  Treatment with Lupron Depot-PED helps to arrest pubertal development until a more appropriate time.  

"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," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.  

Patients with central precocious puberty who have been prescribed Lupron Depot-PED receive an injection that is administered in the physician office.  The three current strengths of Lupron Depot-PED are given to patients once a month.  Now, patients who are prescribed the newly approved formulation may receive their treatments every three months.  

Lupron Depot-PED works by suppressing the level of hormones that cause puberty. This decrease in the production of certain hormones delays premature puberty until a more appropriate time in the child's life.

Abbott's submission to the FDA was supported by new data from a 24-week, open-label study involving 84 patients with central precocious puberty.  Patients received a total of two injections, 12 weeks apart, and were followed for nearly six months to evaluate hormone suppression and safety.  Overall, hormone suppression with the new three-month depot formulation in both strengths was sustained in patients throughout the treatment period.  In patients who had not been previously treated for CPP, the onset of hormone suppression was consistent with other currently available Lupron Depot-PED formulations.  The most common side effects from this study were injection-site pain, weight gain, headache, altered mood and injection-site swelling.  The three-month formulation is expected to be available in late August.