Kyowa Hakko to Seek FDA Approval for Parkinson's Disease Drug
Posted on: Tuesday, 7 March 2006, 18:00 CST
Tokyo, March 7 (Jiji Press)--Kyowa Hakko Kogyo Co. said Tuesday it plans in the second half of 2006 to apply for the approval of the U.S. Food and Drug Administration for its new Parkinson's Disease drug.
Kyowa Hakko will submit the application after the completion of three types of Phase III clinical studies on the drug, codenamed KW- 6002, to be carried out in the United States and Europe, it said.
Parkinson's Disease is caused by a shortage of neurotransmitter dopamine in the brain. The disease is mainly treated by administering L-DOPA, a dopamine precursor. But long-term therapy with L-DOPA causes a shortening of the period of response to each dose, known as the wearing-off phenomenon.
Kyowa Hakko confirmed in one of the clinical studies that KW- 6002 led to an improvement in the wearing-off phenomenon. In the other two studies, it found that the drug improved the motor functions of patients, it said.
Kyowa Hakko said KW-6002 would contribute to relieving various symptoms.END
Source: Jiji Press English News Service
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