January 18, 2015
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Congenital adrenal hyperplasia therapy granted orphan drug status

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The FDA has granted orphan drug status to Neurocrine Biosciences, Inc., for NBI-77860, a proprietary corticotropin releasing factor 1 receptor antagonist for the treatment of congenital adrenal hyperplasia.

“We are very pleased that the FDA has granted NBI-77860 orphan status to treat congenital adrenal hyperplasia, a devastating disease that is a significant challenge for both clinicians and patients,” Malcolm Lloyd-Smith, chief regulatory officer or Neurocrine Biosciences, said in the release. “This status represents a significant regulatory milestone for the [congenital adrenal hyperplasia] program and underscores that importance of bringing a safe and effective [congenital adrenal hyperplasia] therapy to market. We look forward to the results from our recently initiated 1401 Study of adolescents with class [congenital adrenal hyperplasia], in 2015.”