FDAnews
www.fdanews.com/articles/78765-fda-approves-drug-for-children-with-growth-failure

FDA APPROVES DRUG FOR CHILDREN WITH GROWTH FAILURE

September 2, 2005

The FDA has approved the first drug to treat children who suffer from a condition that prevents them from growing.

Incelex, manufactured by Tercica, 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.

In the trial, which involved 71 patients, children given Increlex gained an additional inch per year compared with their previous growth patterns. Side effects included low blood sugar and skin lumps, but no patients withdrew from the trial because of them.