Takeda Obtained New Drug Application Approval of “Leuplin PRO for injection kit 22.5 mg”

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The FINANCIAL — Takeda Pharmaceutical Company Limited on September 28 obtained New Drug Application approval of “Leuplin PRO for injection kit 22.5 mg” (generic name: leuprorelin acetate), which is the 24 week depot of “Leuplin”, a treatment for prostate cancer and premenopausal breast cancer, from the Japanese Ministry of Health, Labour and Welfare.

Created and developed by Takeda, Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormones. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available in the United States, Europe, and Asia, according to Takeda.

Leuprorelin acetate was initially approved as a once-daily injection administration in the United States in 1985, but Takeda has applied multiple innovations, based on its expertise in drug formulation technology, to turn it into a sustained-release microcapsule depot formulation, enabling it to maintain stable blood concentration levels over a long period of time. At present, both 4 week and 12 week formulations are marketed in Japan.

This approval is based on the results of two clinical phase III multicenter, randomized, open label, comparative studies evaluating safety, efficacy, pharmacokinetics, hormone dynamics, and other factors in patients with prostate cancer and those with premenopausal breast cancer. Leuplin PRO becomes the world’s first product to obtain approval for the treatment of premenopausal breast cancer for 24 week depot.

By delivering this new treatment for both prostate cancer and premenopausal breast cancer, Takeda looks forward to further contributing to meeting the needs of patients and healthcare professionals.  


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