Encouraging Ph III data for Kyowa Hakko's PD drug

Japanese drugmaker Kyowa Hakko Kogyo Co has completed three Phase III efficacy and safety studies of KW-6002 (istradefylline), an agent developed in-house for the treatment of Parkinson's disease, for patients whose L-DOPA is wearing off. Only one of the studies revealed a statistically-significant reduction in the percentage of awake time spent in the state of L-DOPA inefficacy. In the other two, the observed reduction was not significant compared with placebo, but they did show a significant improvement or a trend toward improvement in one of the secondary endpoints, the motor function score, assessed using the Unified PD Rating Scale subscore III. The Chiyoda-ku, Tokyo-headquartered firm intends to submit a New Drug Application on the agent to the US Food and Drug Administration in the latter half of this year.