WEDNESDAY, Aug. 31, 2005 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the Tercica drug Increlex to treat children of short stature whose bodies don't properly process growth hormone.
An estimated 6,000 children in the United States have a severe form of a condition in which they produce antibodies that neutralize growth hormone. These children are not growth-hormone deficient and therefore aren't likely to respond to standard growth hormone replacement therapy, Tercica said in a statement.
Children with severe IGF-1 deficiency lack a body chemical called insulin-like growth factor-1, which is needed for the normal growth of bones, cartilage and organs, said Tercica, a Brisbane, Calif., biotech company.
The FDA granted "orphan drug" status to Increlex for severe IGF-1 deficiency, giving the company seven years of exclusive rights to the drug for this use, Tercica said.
To learn more about the Increlex approval, visit Tercica's Web site.