U.S. OKs Hormone
for Short Kids
Reuters
11:03 AM Jul. 27,
2003 PT 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
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