US FDA Accepts Regulatory Submission of New Drug Application for Selumetinib in Neurofibromatosis Type 1 (NF1) and Grants Priority Review

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KENILWORTH, N.J.

AstraZeneca and Merck’s Selumetinib Would Become the First Medicine Indicated for the Treatment of Certain Pediatric Patients with NF1 Plexiform Neurofibromas if Approved

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs).

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English

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Media:
Pamela Eisele
(267) 305-3558

Steve Wanczyk
(267) 305-5563

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Peter Dannenbaum
(908) 740-1037

Courtney Ronaldo
(908) 740-6132

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MRK

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NYSE

@Merck

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