Neurocrine gets guidance for filing Parkinson's drug for US approval

15 February 2018

The US Food and Drug Administration has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson's disease, after receiving meeting minutes from the January 2018 meeting with the FDA.

US biotech firm Neurocrine Biosciences (Nasdaq: NBIX) acquired North American rights to Ongentys (opicapone) that was approved in June 2016 by the European Commission as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations, from Portugal’s BIAL in February 2017.

Under the terms of the deal, and as a result of the FDA guidance for the NDA filing, Neurocrine will now make a $10 million milestone payment to BIAL.

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