AstraZeneca and MSD (Merck) announced today that the U.S. Food and Drug Administration (FDA) has granted acceptance to file status of its application for the MEK inhibitor selumetinib, for use in patients with plexiform neurofibromas, a common manifestation in the disease neurofibromatosis type one (NF1). The FDA’s acceptance of the application is a major milestone for selumetinib becoming the first ever approved treatment for NF patients. This follows previous designations from the FDA granting the treatment orphan drug status as well as breakthrough status, and now enters the drug into the FDA’s approval pipeline. The FDA also granted priority review, and a PDUFA (Prescription Drug User Fee Act) has been set for the second quarter of 2020.
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