gorilla_boy
Special
Story location: http://www.wired.com/news/medtech/0,1286,59793,00.html
11:03 AM Jul. 27, 2003 PT
WASHINGTON -- U.S. regulators on Friday approved use of a growth hormone for boosting the height of children who are short but in good health.
Eli Lilly's hormone, Humatrope, has been sold in the United States since 1987 and used for treating children with growth-hormone deficiencies. With the new approval, Indianapolis-based Lilly will be able to market Humatrope for short children with normal levels of the hormone and no evidence of a disease that stunts growth.
The FDA said it approved the treatment for the shortest 1.2 percent of children. For 10-year-old boys and girls, that would correspond to a height of less than 4 feet 1 inch. Their expected adult height without treatment would be less than 5 feet 3 inches for men and 4 feet 11 inches for women.
Humatrope "can enable the majority of these children to achieve an adult height that is within the medically normal range," Lilly spokeswoman Judy Kay Moore said.
An advisory committee in June voted 8-2 to recommend approving Humatrope for the new use after debating whether children who are otherwise healthy should be given multiple injections every week for years in order to grow what may amount to a few inches. At that meeting, Lilly argued that short children often face teasing and bullying, as well as social isolation as adults, and therefore needed a treatment option.
In Lilly's main trial, children treated with Humatrope three times per week grew an average of 1.5 inches more than children given a placebo.
In another study comparing various Humatrope doses given six times per week, children in the high dose group on average exceeded their predicted height by nearly three inches. Some grew even four inches more than predicted, the FDA said.
"Some kids really benefit more than others," said Dr. David Orloff, director of the FDA's division of metabolic and endocrine drug products. Doctors are unsure how to identify which children will respond better, Orloff said.
Eli Lilly will limit marketing of the new use to pediatric endocrinologists and will not advertise directly to consumers, Moore said.
The most common side effects generally are mild and include joint aches, Moore said.
11:03 AM Jul. 27, 2003 PT
WASHINGTON -- U.S. regulators on Friday approved use of a growth hormone for boosting the height of children who are short but in good health.
Eli Lilly's hormone, Humatrope, has been sold in the United States since 1987 and used for treating children with growth-hormone deficiencies. With the new approval, Indianapolis-based Lilly will be able to market Humatrope for short children with normal levels of the hormone and no evidence of a disease that stunts growth.
The FDA said it approved the treatment for the shortest 1.2 percent of children. For 10-year-old boys and girls, that would correspond to a height of less than 4 feet 1 inch. Their expected adult height without treatment would be less than 5 feet 3 inches for men and 4 feet 11 inches for women.
Humatrope "can enable the majority of these children to achieve an adult height that is within the medically normal range," Lilly spokeswoman Judy Kay Moore said.
An advisory committee in June voted 8-2 to recommend approving Humatrope for the new use after debating whether children who are otherwise healthy should be given multiple injections every week for years in order to grow what may amount to a few inches. At that meeting, Lilly argued that short children often face teasing and bullying, as well as social isolation as adults, and therefore needed a treatment option.
In Lilly's main trial, children treated with Humatrope three times per week grew an average of 1.5 inches more than children given a placebo.
In another study comparing various Humatrope doses given six times per week, children in the high dose group on average exceeded their predicted height by nearly three inches. Some grew even four inches more than predicted, the FDA said.
"Some kids really benefit more than others," said Dr. David Orloff, director of the FDA's division of metabolic and endocrine drug products. Doctors are unsure how to identify which children will respond better, Orloff said.
Eli Lilly will limit marketing of the new use to pediatric endocrinologists and will not advertise directly to consumers, Moore said.
The most common side effects generally are mild and include joint aches, Moore said.
