Takeda Pharmaceutical is seeking approval from the Japanese Ministry of Health Labour and Welfare for its Leuplin six month depot (leuprorelin acetate) to treat prostate and premenopausal breast cancer.
A new drug application (NDA) to this effect has been submitted by the company to the Japanese ministry.
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Leuplin is an LH-RH agonist, which consistently stimulates the pituitary gland to suppress the production of male/female hormone.
The company submitted the application based on the results of two clinical Phase III studies in patients with prostate cancer and those with premenopausal breast cancer through multicentre, randomised, open label and comparative studies.
Studies assessed the safety, efficacy, pharmacokinetics and hormone dynamics, according to the company.
Initially, Takeda launched Leuplin as a once-daily administration by injection.
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By GlobalDataFollowing use of several applications in drug formulation technology, the company was able to develop Leuplin into a sustained-release microcapsule depot formulation, enabling to maintain stable blood concentration levels over a long period of time.
Currently, one month and three month formulations have received approval and are marketed in Japan.
The six month depot allows the treatment with one administration at every 24 weeks, are is now available in markets such as the US, Europe and a few countries in Asia.
Takeda said that the new treatment for both prostate cancer and premenopausal breast cancer will be delivered through its drug delivery system.
