Pharmaceutical Business review

Kyowa files for Parkinson’s therapy approval

Istradefylline(KW-6002) is an anti-Parkinson’s drug that has a specific antagonistic action on the adenosine A2A receptor in the brain and is expected to provide benefit to patients with Parkinson’s disease.

The symptoms of Parkinson’s disease are treated primarily by dopamine replacement therapy with Levodopa or dopamine agonists. Long term therapy with Levodopa is associated with motor complications such as the development of a shortening response to each dose, which is called “wearing-off phenomenon”, and involuntary movements.

Phase II and III clinical studies were conducted with Istradefylline (KW- 6002) in Parkinson’s disease patients experiencing “wearing-off phenomenon” on treatment with Levodopa alone or Levodopa administered concomitantly with other Parkinson’s disease medications.

Based on the clinical efficacy and safety data obtained, the company submitted a new drug application for Istradefylline(KW-6002) as adjunctive therapy to levodopa for the treatment of idiopathic Parkinson’s disease, to improve motor function in patients who experience motor response complications.