Separately, Hyperion announced it has received notification from the
"With FDA approval of RAVICTI, we are now in a position to commercialize Hyperion's first product. Furthermore we believe that the allowed claims, once issued, will provide important protection for the use of RAVICTI to treat UCD," said
"We believe the RAVICTI development program has brought not only a promising new drug to the UCD community, but also a much deeper understanding of UCD treatment," said Dr.
Hyperion intends to commercially launch RAVICTI by the end of April. As part of the commercialization of RAVICTI, Hyperion today announced the launch of a dedicated call center,
RAVICTI Indications, Usage and Safety Information
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ two years of age with urea cycle disorders (UCDs) that 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, protein-free calorie supplements).
Limitations of Use:
RAVICTI is Contraindicated in Patients:
The major metabolite of RAVICTI, PAA, is associated with neurotoxicity at levels ≥ 500 μg/mL. If symptoms of vomiting, nausea, headache, drowsiness, or confusion are present in the absence of high ammonia or other intercurrent illnesses, reduce the RAVICTI dosage.
Pancreatic insufficiency or intestinal 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 in these patients.
Most common adverse reactions in ≥ 10% of patients are: diarrhea, flatulence, headache, nausea, vomiting, fatigue, decreased appetite, hyperammonemia, dizziness, headache, upper abdominal (stomach) pain and rash.
Corticosteroids, valproic acid, or haloperidol may increase plasma ammonia levels; monitor ammonia levels closely when used concomitantly with RAVICTI. Probenecid may affect renal excretion of metabolites of RAVICTI including PAGN and PAA.
The use of RAVICTI in pregnant women may cause fetal harm. Breastfeeding is not recommended during RAVICTI treatment.
Please see full Prescribing Information for RAVICTI at www.hyperiontx.com.
Conference Call and Webcast Information
Hyperion's senior management team will host a conference call on
A telephone replay will be available approximately two hours after the call for one week by dialing 855-859-2056 from the (U.S.) or 404-537-3406 for (International) callers and entering reservation number 96938694. A replay of the webcast will be available on the Events page on the Company's web site for 30 days.
About Urea Cycle Disorders
Urea cycle disorders, or UCDs, are a collection of inherited metabolic disorders in which affected patients suffer from high levels of systemic ammonia, a potent neurotoxin. Ammonia is produced via normal protein ingestion; the body normally detoxifies it by converting it through a series of enzymatic steps to urea, which is excreted in urine. Throughout their lives, UCD patients may experience recurrent hyperammonemic crises in which ammonia levels rise, and can develop complications ranging from nausea, vomiting and headache to coma and death.
This press release includes forward-looking statements reflecting management's current beliefs and expectations about future events; these forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations regarding the timing and effectiveness of any commercial launch of RAVICTI, the timing of availability of RAVICTI to physicians and patients, our plans with respect to distribution of RAVICTI with specialty pharmacies, the launch of a dedicated call
center and our plans with respect to the development of RAVICTI to treat HE. Forward-looking statements in this release involve substantial risks and uncertainties that could cause future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to: the success and timing of commercialization and distribution efforts; the fact that the patient population suffering from UCD is small and has not been established with precision; uncertain ability to hire and retain qualified personnel to assist with those commercialization and distribution efforts; risks associated with our ability to obtain adequate commercial and clinical supplies of RAVICTI; uncertainties associated with physician acceptance of RAVICTI, patient and physician response to pricing of the
drug and government or insurance reimbursement of the drug; and the uncertain ability to raise sufficient capital to complete the development and commercialization of RAVICTI in HE. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see for example Hyperion's Current Report on Form 8-K filed with the
Myesha Edwards, Investor Relations (650) 745-7829 firstname.lastname@example.org Kristie Kuhl, Media Relations (203) 556-7417 email@example.com
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