Horizon Pharma plc HZNP announced that it has filed a supplemental new drug application with the FDA seeking label expansion for Ravicti (glycerol phenylbutyrate) oral liquid. The company is looking to expand the age range for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two months of age to two years of age and older. The company’s shares jumped 6.9% on the news.
Currently, Ravicti is approved in the U.S. for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than two years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation.
We are encouraged by Horizon Pharma’s efforts to expand Ravicti’s label further. We note that Ravicti became a part of the company’s portfolio as a result of the May 2015 Hyperion Therapeutics acquisition.
Ravicti recorded sales of $37.1 million in the first quarter of 2016. Label expansion would boost the drug’s sales further.
Additionally, Horizon Pharma partnered with Clinigen Group's Idis Managed Access division to initiate a Managed Access Program (MAP) in select European countries for eligible, individual patients living with UCDs. The MAP will allow healthcare professionals to access Ravicti while Horizon Pharma works through its country-by-country plan to make Ravicti commercially available in Europe. We note that Ravicti was approved in Europe in Nov 2015.
Horizon Pharma is currently a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Retrophin, Inc. RTRX and Bristol-Myers Squibb Company BMY. All three stocks sport a Zacks Rank #1 (Strong Buy).
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