FDA Advisory Committee Recommends Approval for Expanded Use of Growth Hormone
An FDA advisory committee yesterday voted 8-2 to recommend approval for expanded use of Humatrope, a synthetic growth hormone manufacturer Eli Lilly seeks to make available to short children without growth-hormone deficiencies, Reuters/Boston Globe reports (Reuters/Boston Globe, 6/11). Since 1987, about 200,000 short children worldwide whose bodies do not produce growth hormones have used Humatrope (AP/St. Petersburg Times, 6/11). Eli Lilly hopes to market Humatrope to children who are in the first percentile of their height and are likely to grow to less than 5 feet 3 inches for males or 4 feet 11 inches for females. In clinical trials, participants who took Humatrope grew an average of one to 1.5 inches more than those who took a placebo; 62% of participants who took the medication grew more than two inches over their expected height, and 31% grew more than four inches over their expected height, according to an FDA statistical review provided to the committee (Callahan/Abboud, Wall Street Journal, 6/11). "For some individuals one, one and a half inches, may be clinically meaningful. For others it won't be, but they need to make that decision," Dr. Glenn Braunstein, committee chair and an endocrinologist at the UCLA School of Medicine, said (Reuters/Boston Globe, 6/11).
Harvey Guyuda, a pediatric endocrinologist from McGill University, raised some concerns to committee members about Humatrope. He said that many short children "see their growth catch up over time" and that "studies suggesting that growth hormones boost their height are too few to believe," the Indianapolis Star reports (Swiatek, Indianapolis Star, 6/11). In addition, Guyuda raised concerns about the cost of Humatrope. Children who take Humatrope receive injections three to six times per week for two to five years until they reach their adult heights, and the treatment costs between $10,000 and $20,000 per child per year, according to Eli Lilly. However, Guyuda told the committee that the cost could reach as high as $43,000 for each centimeter of growth (Wall Street Journal, 6/11). Committee members also raised concerns about the proper age at which children should begin treatment with Humatrope and the practices that physicians should use to determine which children should end treatment because they will not respond. They also asked for additional research on the administration of Humatrope and recommended that Eli Lilly track children who receive the medication under the terms of approval for expanded use (AP/St. Petersburg Times, 6/11).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.