AztraZeneca, MSD neurofibromatosis drug application accepted, granted priority review in US

  • Thu 14 Nov 2019 07:36

    AstraZeneca and MSD said their application for a drug used to treat paediatric patients suffering from neurofibromatosis had been accepted by the US Food and Drug Administration and granted priority review.

    This was the first acceptance of a regulatory submission for an oral monotherapy for the treatment of neurofibromatosis type 1 (NF1), a rare and incurable genetic condition.

    A prescription drug user fee act date was set for the second quarter of 2020.

    The regulatory submission was based on positive results from a trial, which showed an objective response rate was achieved in 66% of paediatric patients with NF1 and when treated with selumetinib as a twice-daily oral monotherapy.

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