Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
KIRIN HLDGS CO LTD S/ADR (KNBWY)
US:NASDAQ Investor Relations:
kirinholdings.co.jp/english/ir
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Source: Business Wire
TOKYO--(BUSINESS WIRE)-- Kyowa Hakko Kirin Co., Ltd. (TOKYO:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for istradefylline (KW-6002), an investigational selective adenosine A2A receptor antagonist, for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in August 27, 2019. The submission is based on findings from randomized, multi-center, double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications. "People living with Parkinson's Disease have difficulty moving that often worsens during 'off' periods, and there is a si
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