(By Balachander) Hyperion Therapeutics Inc.'s (NASDAQ: HPTX) new drug to treat urea cycle disorders (UCDs) has won approval from the U.S. health regulators.
The U.S. Food and Drug Administration (FDA) cleared Ravicti (glycerol phenylbutyrate) for the chronic management of some UCDs in patients ages 2 years and older.
UCDs are genetic disorders that involve deficiencies of specific enzymes involved in the urea cycle, a series of biochemical steps normally required to remove ammonia from the blood.
Ravicti also was granted orphan product designation because it is intended to treat a rare disease, the FDA said.
According to the FDA, a major study showed Ravicti was as effective as Buphenyl - another drug approved to control UCDs - in controlling ammonia levels.
The most common side effects in patients treated with Ravicti include diarrhea, flatulence and headache.
The South San Francisco, California-based company is focused on developing therapeutics for orphan diseases and hepatology.
The stock, which has been trading in the 52-week range of $9.95 to $16.34, traded 3.20 percent higher at $16.13 on Friday.