FDA accepts Kyowa Hakko's refiling for PD drug istradefylline

The US Food and Drug Administration 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.

Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) received approval for Nouriast (istradefylline) in the adjunctive treatment of PD in Japan in 2013. An NDA was filed in the USA, but the FDA issued a non-approvable letter in February 2008, citing concerns about its efficacy. In 2016, the drug failed to beat placebo in a Phase III study.

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.