Selumetinib Granted Orphan Drug Designation by the U.S. FDA for Neurofibromatosis Type 1
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1). NF1 is an incurable genetic condition that affects one in 3,000 births with highly-variable symptoms including cutaneous (skin), neurological (nervous system) and orthopedic (skeletal) manifestations. NF1 can cause secondary complications including learning difficulties, visual impairment, pain, disfigurement, twisting and curvature of the spine, high blood pressure and epilepsy. Plexiform neurofibromas (PNs) are tumors that arise from nerve fascicles and tend to grow along the length of the nerve. PNs, a neurological manifestation of NF1,occur in approximately 20-50 percent of NF1 patients causing pain,
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