Kyowa Hakko’s Parkinson’s Drug Is Not Approvable – U.S. FDA
This article was originally published in PharmAsia News
Executive Summary
Kyowa Hakko will work with U.S. FDA to determine a path forward for its Parkinson's treatment istradefylline (KW-6002) after receiving a "not approvable" letter from the agency Feb. 25, the Tokyo-based firm said Feb. 27
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Kyowa Hakko will work with U.S. FDA to determine a path forward for its Parkinson's treatment istradefylline (KW-6002) after receiving a "not approvable" letter from the agency Feb. 25, the Tokyo-based firm said Feb. 27. In its not approvable letter, FDA "expressed concern if the efficacy findings support clinical utility of istradefylline," Kyowa Hakko said. "FDA requested an overall summary of nonclinical mineralization findings. Additionally, FDA asked for clinical pharmacology follow-up information as a Phase 4 commitment." Kyowa Hakko's U.S. subsidiary, Kyowa Pharmaceuticals, submitted the NDA for istradefylline on April 25, 2007 (Also see "ArQule Gets $30 Million Up Front From Kyowa In Oncology Deal" - Scrip, 30 Apr, 2007.). The company is seeking approval for the adenosine A2A receptor antagonist as an adjunctive therapy to levodopa/carbidopa for treatment of idiopathic Parkinson's disease to improve patient motor function. Kyowa Hakko and Kirin Holdings recently announced plans to merge to create a Japanese-based global life sciences business with a focus on biotechnology (Also see "Japan's Kirin, Kyowa Merge To Strengthen Biotechnology Focus" - Scrip, 24 Oct, 2007.) - Joshua Berlin ([email protected]) |