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

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.

Separately, Hyperion announced it has received notification from the US Patent & Trademark Office (USPTO) of the allowance of the claims of patent application number 13/417,137, which discloses optimal measurement timing and target levels for blood ammonia in UCD patients. The issued patent would have a term that expires in March 2032. After issuance, Hyperion plans to list this patent in FDA's Approved Drug Products with Therapeutic Equivalence, or Orange Book.