FDA OKs Experimental Drug Injections for Short Children

The Food and Drug Administration approved an experimental drug to treat very short children who do not seem to respond to their own natural hormones, the drug’s maker said Wednesday.

The drug is the first approved product for Brisbane, Calif.-based Tercica Inc., which licensed the rights from South San Francisco-based Genentech Inc. Tercica shares rose more than 21%, while shares of its main rival, Insmed Inc., fell more than 35%.

FDA officials cleared the injectable drug, called Increlex, to treat children with severe primary insulin-like growth factor-1 deficiency (Primary IGFD) or those who have developed antibodies that neutralize the hormones.

Insulin-like growth factor-1, or IGF-1, helps direct growth hormone’s effect and must be present for children’s bones, cartilage and organs to grow normally.

The drug is the latest therapy in a growing but controversial field of drugs targeting children’s height.

Drug makers and others say short children can suffer from teasing and other social problems and should be treated.

Other experts say people naturally vary in height and have growth spurts at various ages. They add it is unclear what long-term effects the drugs will have on growing children.

Insmed, which is seeking FDA approval for its version of the drug called SomatoKine, filed a petition with the agency last month and called for the agency to reject Increlex because it said Tercica failed to prove the drug’s safety.

Tercica shares rose $1.98 to $11.31 while Insmed shares fell 53 cents to 93 cents.