The Food and Drug Administration has approved the first drug to treat children who suffer from a condition that prevents them from growing, the drug's manufacturer says.
Until now, growth hormones have been the only treatment option for children short in stature because of hormone deficiencies, said Dr. Philippe Backeljauw of Cincinnati Children's Hospital. He was a researcher in the trial for the new drug, Increlex.
The drug, Backeljauw said, helps children whose growth failure is linked to abnormally low levels of a hormone called IGF-1. About 6,000 children in the U.S. are afflicted by the condition, according to Increlex's manufacturer, Tercica Inc. of Brisbane.
In the trial, which involved 71 patients, children given Increlex gained an additional inch per year compared with their previous growth patterns, the company said. Side effects included low blood sugar and skin lumps, but the company said no patients withdrew from the trial because of them.
Tercica began U.S. operations in 2002 after licensing exclusive rights to develop the growth drug from the biotech company Genentech, according to Tercica's Web site.