DUBLIN, IRELAND--(Marketwired - Jan 4, 2016) - Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for U.S. patent application number 14/816,674 (U.S. publication number 2015-0335605), entitled "Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs" that covers Horizon's U.S. approved medicine RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid.
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire in 2032. After issuance, Horizon plans to list the U.S. patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
About RAVICTI®
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline and protein-free calorie supplements). RAVICTI is indicated for use in all 28 Member States of the European Union and 3 Member States of the European Economic Area as a nitrogen-binding agent for chronic management of adult and pediatric patients two months of age and older with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Important Safety Information
LIMITATIONS OF USE:
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RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels
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The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established
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The use of RAVICTI in patients < 2 months of age is contraindicated
CONTRAINDICATIONS:
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In patients less than 2 months of age
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In patients who develop or have known hypersensitivity to phenylbutyrate
WARNINGS AND PRECAUTIONS:
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Phenylacetate (PAA), the major metabolite of RAVICTI, may be toxic at levels ≥500 µg/mL. Reduce RAVICTI dosage if symptoms of neurotoxicity, including vomiting, nausea, headache, somnolence, confusion, or sleepiness are present in the absence of high ammonia or other intercurrent illnesses.
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Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely.
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RAVICTI should be used with caution in patients who are pregnant or planning to become pregnant. Based on animal data it may cause fetal harm. A voluntary patient registry will include evaluation of pregnancy outcomes in patients with UCDs. For more information regarding the registry program, visit www.ucdregistry.com or call 1-855-823-2592
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Caution should be exercised when administering RAVICTI to nursing mothers, as breastfeeding is not recommended with maternal use of RAVICTI. It is not known whether RAVICTI or its metabolites are present in breast milk