FDA Approves Humatrope For Short Stature

[Lee J B]

Found this interesting, could be the change of the tide for a few things to come if you know what I mean. Thought a few of you guys might like to see this.

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FDA Talk Paper
T03-56
July 25, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA




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.

[DaLinkWent]

Yeah interesting stuff . . . I saw the world news the day the FDA announced this and they think problems could stem from people who think that their child isn't tall enough for their standards and doctors prescribing this to give kids a quick juimp in height.

Kinda scary that you can pretty much chnage anything you want now

[casanova88]

*edit* i find it very ironic they want to take away ephedra and prohormones, and start giving hGH to people just because they're short

if this is covered by insurance premiums will hit the roof once ppl start making use of it. hGH is really expensive

Curious why you consider hGH dangerous, casanova?

[qlharvey]

Doc will measure HGH and IGF-1 levels in the blood stream... if they are lower than normal (for a child of X age), they will prescribe HGH in amounts to make up for the deficit.

[Storm]

Originally Posted by qlharvey

Doc will measure HGH and IGF-1 levels in the blood stream... if they are lower than normal (for a child of X age), they will prescribe HGH in amounts to make up for the deficit.

I find this very hard to believe, HGH cycle through the blood stream in established patterns but it will be increadibly difficult to say this person is or this person is not deficient mainly because the paterns while consistant for the individual are not consitant throughout the population. In fact in most growth hormone studies you see a spike in the 0-2 years followed by a gentle decrease followed by another spike in the sexual maturity, then slow decline to death.

I believe from the studies done in the past they will continue to look for defects in the HGH pathway or production sites before they administer this treatment. Plus they have been doing this for years just entirely off label.

[casanova88]

lee - i think maybe the statement i made might be made in a bit of haste. administered by a doctor in normal doses should not pose too great a risk. i was thinking along the lines of an inexperienced user. most of the time on boards when talking hGH or the like its to normal people not by use of medical professionals. my mind might have been in the wrong mindset. because hGH does increase the size of the whole body - organs, etc. included, its not something to mess around with, but if administered by and monitored by a doctor, most of the risk should be eliminated. on the other hand there are numerous to have high levels of hGH in your system.

[shades6234]

Originally Posted by Storm

I find this very hard to believe, HGH cycle through the blood stream in established patterns but it will be increadibly difficult to say this person is or this person is not deficient mainly because the paterns while consistant for the individual are not consitant throughout the population. In fact in most growth hormone studies you see a spike in the 0-2 years followed by a gentle decrease followed by another spike in the sexual maturity, then slow decline to death.

I believe from the studies done in the past they will continue to look for defects in the HGH pathway or production sites before they administer this treatment. Plus they have been doing this for years just entirely off label.

I have just been skimming this post....but would it be bad to inject a 65 year old man who has almost no HGH left. Would that help extend life? Do woman start their second spike later than men?

[casanova88]

LOL - shades you make it sound like you're going to go stick some old man in his sleep

but yes hGH has been attributed many "fountain of youth" qualities for an aging individual. you should go online and do a search on the subject (if you want specifics) theres lots of info out there

[Storm]

HGH has been atributed to several extended life studies though I really put little stock in them, the biggest problem is the cost. I have isolated HGH and to get it into a stable cell line is a serious pain in the butt, production numbers are always next to impossible to get without significant cost to the consumer.

That being said yes if you could get enough HGH to suppilment your body's decreasing function you could have some effect. Now I say some not good, one because HGH has been liked with canser cell matastasis, among other nasty things and two, HGH when increased in the body when you are not a teenager puts termendious strain on your joint's specifically your knees and elbow's, plus you get growth of the lower intestine which gives you that wonderful beer belly look that some of the current lifters have right now.

[Lee J B]

There are ways, doses and cycles arriving out now that will stop just about all of the side effects, even the beer belly look....it would be even safer but they can't afford to experiment with it, as you guys have said it's hella expensive.

[Storm]

yeah the current cost is outragous for the benifit you get, but I assume at those levels anything that get help you at all is tried, it is deffinitly not on my list of AS to try in the next couple years.