Regulatory news for Hyperion's Ravicti and Seattle Genetics' Adcetris

4 February 2013

The US Food and Drug Administration on Friday approved Hyperion Therapeutics’ (Nasdaq: HPTX) Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients aged two years and older.

Ravicti was reviewed under the FDA’s fast track program, designed to facilitate the development and expedite the review of drugs to treat serious diseases earlier. Ravicti also was granted orphan product designation because it is intended to treat a rare disease.

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