The FDA is reviewing Abbott’s supplemental New Drug Application for a new six-month 45-mg formulation of Lupron Depot (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer. Lupron Depot works by suppressing production of testosterone, which helps slow or stop the growth of hormone-dependent prostate cancer cells.
“Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit from this medication,” said Eugene Sun, MD, Vice President for Global Pharmaceutical Development at Abbott.
Abbott says its submission is supported by new data from a 48-week study involving 300 patients with prostate cancer. Patients received a total of two injections, 24 week apart and were followed for nearly one year. Overall, testosterone suppression with the six-month formulation was sustained in patients throughout the treatment period.