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Hyperion
Therapeutics, Inc.
today announced that the U.S. Food and Drug
Administration (FDA) has approved RAVICTI for the treatment of Urea Cycle
Disorders (UCD) in patients two years of age and older. The drug is expected
to be commercially available by the end of April 2013.
Separately, Hyperion announced it has received notification from the U.S.
Patent & Trademark Office (USPTO) of the allowance of the claims of patent
application number 13/417,137 entitled, METHODS OF THERAPEUTIC MONITORING OF
NITROGEN SCAVENGING DRUGS, which discloses optimal measurement timing and
target levels for blood ammonia in UCD patients. A Notice of Allowance is
issued after the USPTO makes a determination that a patent can be granted from
an application. 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.
"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 Donald J. Santel, Hyperion's chief executive officer. "We thank our
clinical trial patients, their families, our investigators and study
coordinators, the UCD Consortium, and the National Urea Cycle Disorders
Foundation – in particular NUCDF Executive Director Cynthia Le Mons – for
their collaboration and support of our development efforts."
The FDA approval of RAVICTI was based on a New Drug Application (NDA) that
included data from 10 clinical trials, including six in UCD patients, that
involved 23 sites, over 50 investigators and sub-investigators, and
approximately a dozen referring metabolic specialists throughout North
America. As part of FDA approval, Hyperion agreed to post-marketing
requirements that include: studies of RAVICTI safety, ammonia control, and
pharmacokinetics in pediatric UCD patients in the first two months of life and
from two months to two years of age; studies in healthy adults to examine
drug-drug interaction and whether RAVICTI metabolites are present in breast
milk; a randomized controlled clinical trial to assess the safety and efficacy
of RAVICTI in treatment-naïve patients with UCD; and a UCD registry of
approximately 10 years duration. Importantly, the FDA did not require a Risk
Evaluation and Mitigation Strategy (REMS) program.
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