Discovered and developed by Takeda, Leuplin is an LH-RH agonist that stimulates the pituitary gland, resulting in suppressed production of male/female hormone.
The NDA is based on the results of two clinical Phase III trials in patients with prostate cancer and those with premenopausal breast cancer through multicenter, randomized, open label, comparative trials, assessing the safety, efficacy, pharmacokinetics, hormone dynamics and others.
Initially, Leuplin was launched as a once-daily administration by injection, and is currently available across the world.
The company has applied multiple innovations, based on its expertise in drug formulation technology, to turn Leuplin into a sustained-release microcapsule depot formulation, enabling to maintain stable blood concentration levels over a long period of time.
The company said that six-month depot becomes the world’s first submission to treat premenopausal breast cancer. Currently, both one month and three month formulations have been approved and are marketed in Japan.
Image: Headquarters of Takeda Pharmaceutical in Osaka, Japan. Photo: courtesy of J o.