FDA Grants Breakthrough Therapy Designation to Lenti-D™ for the Treatment of Cerebral Adrenoleukodystrophy
bluebird bio, Inc. (BLUE)
Last bluebird bio, inc. earnings: 2/18 04:05 pm
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Lenti-D™ for the treatment of patients with cerebral adrenoleukodystrophy (CALD), a rare, serious and life-threatening hereditary neurological disorder. Breakthrough Therapy designation is designed to expedite the development and review of a drug intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. “The founding of bluebird was inspired by the potential to develop a one-time gene therapy for boys suffering from this potentially fatal form of adrenoleukodystrophy,” said David Davidson, M
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