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AZN:FDA Accepts Regulatory Submission For Selumetinib In Neurofibromatosis Type1

AstraZeneca (AZN.L,AZN) and Merck & Co., Inc. said that the US Food and Drug Administration has accepted a New Drug Application and granted Priority Review for selumetinib as a potential new medicine for paediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs).

AstraZeneca that it is the first acceptance of a regulatory submission for an oral monotherapy for the treatment of NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act date is set for the second quarter of 2020.

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