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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.