Mudge

FDA Approves Humatrope for Short Stature

The Food and Drug Administration (FDA) today approved a new indication for Humatrope (Somatropin, rDNA origin, for injection), a brand of growth hormone, for the long-term treatment of children with idiopathic (of unknown origin) short stature, also called non-growth hormone deficient short stature.

"Short stature" has been defined by the American Association of Clinical Endocrinologists and the Growth Hormone Research Society as height more than 2 standard deviations (SD) below the mean for age and sex. This corresponds to the shortest 2.3 percent of children. This new indication restricts therapy to children who are even shorter, specifically more than 2.25 SD below the mean for age and sex, or the shortest 1.2% of children. For example, for 10-year old boys and girls, this would correspond to heights of less than 4' 1" inch. This would further correspond to heights of less than 5' 3" and 4' 11" in adult men and women, respectively.

Today's approval was based on 2 randomized, multicenter trials, conducted in approximately 300 children with idiopathic short stature. The diagnosis of idiopathic short stature was made after excluding other causes of short stature, including growth hormone deficiency.

The pivotal trial was a randomized, double-blind study in 71 children aged 9-15 years. Patients received injections of either Humatrope or placebo three times weekly until adult height was reached. Thirty-three patients contributed final height measurements after a mean treatment duration of 4.4 years. Mean final height of the Humatrope patients exceeded that of the placebo patients by approximately 1.5 inches.

In a second study, patients received one of three increasing doses of Humatrope, in divided doses six times weekly. The average duration of treatment to final height was 6.5 years. Final height exceeded that predicted at the time of enrollment in the majority of patients, and by up to nearly four inches in some. In the high-dose group, mean final height exceeded mean height predicted at baseline by nearly three inches.

The safety profile of Humatrope in children with idiopathic short stature did not differ from that in children with other conditions for which growth hormone is indicated.

Various growth hormone products are currently indicated in children for short stature associated with growth hormone deficiency, chronic renal insufficiency, Turner syndrome, Prader-Willi syndrome, and in children born small for gestational age.

Humatrope's new indication for idiopathic short stature is the first indication for growth hormone in children that specifies a height restriction (see above).

On June 10, 2003, the application for this new indication was presented to FDA's Endocrine and Metabolic Advisory Committee for public discussion and consideration. The advisory committee voted 8-2 in favor of approval.

The manufacturer has advised FDA that it will not engage in direct-to-consumer advertising of Humatrope and will limit the marketing of this product for this new use to pediatric endocrinologists in order to better ensure the proper use of this product in the indicated pediatric population. In addition, the manufacturer intends to tightly control the distribution of Humatrope.

Humatrope is manufactured and distributed by Eli Lilly Co. of Indianapolis, Ind.

Kinesiology Comp Bench
MaxCalc Motivation Bench form Charles Poliquin
When I let go of what I am, I become what I might be. Lao-Tzu

oaktownboy

all right they made it legal ...now off to the weight room!~

Chuck Norris once lost his keys and couldn't remember where he put them. So he tortured himself for half an hour until he gave up their location.

oaktownboy

well GH is already legal..but at least we got FDA Approval!!!!!

Chuck Norris once lost his keys and couldn't remember where he put them. So he tortured himself for half an hour until he gave up their location.

oaktownboy

my my my now where can we get our hands on that?

Chuck Norris once lost his keys and couldn't remember where he put them. So he tortured himself for half an hour until he gave up their location.

LAM

one of my friends both of his little brothers were put on gh therapy for that back in the early 90's. One was I think 14 and the younger was 11. the younger brother was small but he was bigger than the older brother. both were like 4'0 and light weight for their heightl. 4 years later when I got out of the military one of them was 6'4 250 and the other was 6'6 about 260.

Dumbest statement made in the Anabolic Zone for Nov

TBD

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What you talking about Willis ?

oaktownboy

wow...GH at such an early age though..but man are they built!

Chuck Norris once lost his keys and couldn't remember where he put them. So he tortured himself for half an hour until he gave up their location.

Mudge

Wow, so the GH really did work. I have read a couple years ago that it was debated wether it should be used on children or not, that sounds like 'proof' that it really does work. Part of the debate was that it wasn't really proven to effectively increase height.

Kinesiology Comp Bench
MaxCalc Motivation Bench form Charles Poliquin
When I let go of what I am, I become what I might be. Lao-Tzu

oaktownboy

yeah i also read somewhere that GH for BB is just a "finishing" product for their physique...i think the use of GH is a tricky subject..some people may experience better effects than others...

Chuck Norris once lost his keys and couldn't remember where he put them. So he tortured himself for half an hour until he gave up their location.

Mudge

Yeah, I wouldn't touch it till you got really, really big. Plus the cost is prohibitive.

Kinesiology Comp Bench
MaxCalc Motivation Bench form Charles Poliquin
When I let go of what I am, I become what I might be. Lao-Tzu

Fade

I'm only 5'7".....hmmmmm oh mister Dr sir. hehehehe

crackerjack414

u know this practice with shorter childer was commen in the 70s and early 80s but reversed itself later on. Iam short and it doesnt mater to me, yeah it sucks but ohwell it has its advantages