IGF-1 FDA approved for Growth in Children

[killerdice]

http://www.tercica.com/company/overview.html

[Seattle Junk]

I think GH is a better choice than IGF-1 to induce growth in children since the IGF levels would be more consistent and natural like once the liver starts producing.

[Maetenloch]

The downside is that since it's an approved medication, it may get scheduled by the FDA. Goodbye to IGF as a research chemical.

[Monte Brogan]

Any more thoughts on this, guys? Significant development. IGF is no longer a research drug, as Maetenloch stated.



US FDA approves growth treatment drug for youth
Wed Aug 31, 2005 04:06 PM ET


WASHINGTON, Aug 31 (Reuters) - The U.S. Food and Drug Administration approved an experimental drug to treat very short children who do not seem to respond to their own natural hormones, the drug's maker said on Wednesday.

The drug is the first approved product for Tercica Inc. (TRCA.O: Quote, Profile, Research) , which licensed the rights from Genentech Inc. (DNA.N: Quote, Profile, Research) . Tercica shares rose more than 21 percent, while shares of its main rival, Insmed Inc. (INSM.O: Quote, Profile, Research) , fell more than 35 percent.

FDA officials cleared the injectable drug, called Increlex, to treat children with severe primary insulin -like growth factor-1 deficiency (Primary IGFD) or those who have developed antibodies that neutralize the hormones.

Insulin-like growth factor-1, or IGF-1, helps direct growth hormone 's effect and must be present in order for children's bones, cartilage, and organs to grow normally.

The drug is the latest therapy in a growing but controversial field of drugs targeting children's height.

Drug makers and others say short children can suffer from teasing and other social problems and should be treated.

Other experts say people naturally vary in height and have growth spurts at various ages. They add it is unclear what long-term effects the drugs will have on growing children.

Dr. Paul Kaplowitz, head of endocrinology at Childrens National Medical Center in Washington, said the issue can make parents paranoid. "People are much too worried about kid's growth," he said.

While some health problems can stunt growth, such as rickets or malnutrition, being short can simply be an inherited condition and is not necessarily unhealthy. "Short stature is not necessarily a symptom or sign," according to the National Institutes of Health.

Tercica officials have said some children who can produce growth hormone but resist its effect, just as some diabetics produce insulin but their bodies do not use it properly. The condition can lead to obesity, lower bone density and other problems, they said.

Still, some experts said the number of children lacking the growth factor is small and that the drug should only be used in the worst cases.

"This drug will be useful for a very small number of patients," Kaplowitz said, adding it "will not work as growth hormone in most patients" with growth problems.

About 30,000 youth have the deficiency nationwide, Tercica said. Wednesday's approval applies to 6,000 of those who have the severe form.

Dr. Philippe Backeljauw of Cincinnati Children's Hospital, who conducted studies for Tercica, said the drug "will enable physicians to offer a more specific treatment for children whose growth failure is linked to abnormally low blood IGF-1 levels."

In a Tercica study of 71 children over eight years, researchers found Increlex patients grew an average of one additional inch each year compared to their growth rate before the trial. Side effects included low blood sugar levels and lumps near the injection site.

Insmed, which is seeking FDA approval for its version of the drug called SomatoKine, filed a petition with the agency earlier this month and called for the agency to reject Increlex because it said Tercica failed to prove the drug's safety.

Tercica shares rose $1.98, or 21.22 percent, to $11.31 in late afternoon trade on the Nasdaq, while Insmed shares fell 53 cents, or 36.3 percent, to 93 cents.

[Slic4788]

yah but remember it's rigf, not lr3igf-1.

[Seattle Junk]

Oh man, this sucks if it's scheduled....It'll take about a year to show up I believe? Any way the government/FDA can make a buck. Biggest drug overlords in the world! They don't even have to deal with the product, they just control it. What a scam!

[JohnnyB]

yah but remember it's rigf, not lr3igf-1.

Good point, the rhIGF-1 is approved not LR3 IGF-1

JohnnyB

[Seattle Junk]

Good point, the rhIGF-1 is approved not LR3 IGF-1

JohnnyB

Wouldn't lr3 be a variant of rhIGF-1 so it would fall under the same schedule? I would think so.

[JohnnyB]

Wouldn't lr3 be a variant of rhIGF-1 so it would fall under the same schedule? I would think so.

I'll be honest, I don't know, one thing I do know is Serostims were approved for AIDS wasting diseases, but no other HGH could be used. So I'm going to guess, they are pretty specific about what is approved and what isn't, besides there being no studies out there on humans with LR3 IGF-1. So I'm guessing (again) we're safe for now. Besides LR3's chemical structure is different the rhIGF-1, one has 70 amino acids and LR3 has 83 amino acids, so they are very different

JohnnyB

[Seattle Junk]

I'll be honest, I don't know, one thing I do know is Serostims were approved for AIDS wasting diseases, but no other HGH could be used. So I'm going to guess, they are pretty specific about what is approved and what isn't, besides there being no studies out there on humans with LR3 IGF-1. So I'm guessing (again) we're safe for now. Besides LR3's chemical structure is different the rhIGF-1, one has 70 amino acids and LR3 has 83 amino acids, so they are very different

JohnnyB

Wouldn't these children have to be getting multiple shots throughout the day to make this effective? That's the beauty of lr3. It just seems HGH would be preferred, right? What advantages do they see with rhIGF-1 compared to the proven method of GH?

[JohnnyB]

Wouldn't these children have to be getting multiple shots throughout the day to make this effective? That's the beauty of lr3. It just seems HGH would be preferred, right? What advantages do they see with rhIGF-1 compared to the proven method of GH?

You would think so, with rhIGF-1, it's propably more of a sales pitch, cause I can't see the advantage of rhIGF-1 over HGH or LR3

JohnnyB

[Monte Brogan]

Wouldn't these children have to be getting multiple shots throughout the day to make this effective? That's the beauty of lr3. It just seems HGH would be preferred, right? What advantages do they see with rhIGF-1 compared to the proven method of GH?

Seattle, the kids in the clinicals were taking twice daily injections, correct. I wonder if they'll consider another delivery method. Kids aren't the biggest fans of needles.

[100%NATURAL-theGH]

Growth hormone is administered daily at the minimum... what's one more shot?? it's not like they aren't gonna be used to them... and maybe the IGF is having a more significant impact on growth.. I've seen the break down of how much IGF is given off from GH and it was pretty low in comparison to what straight IGF is... and IGF is what is actually what's responsible for that growth right?? (i apologize for just puting IGF but I'm being lazy!)

[Slic4788]

Well, as far as GH injections are concerened for these kids. It won't work. I think everyone skimmed the article , but these kids have a IGF dificiency, meaning they can't make IGF-1, and have normal/elevated GH levels but no igf.

[Seattle Junk]

Well, as far as GH injections are concerened for these kids. It won't work. I think everyone skimmed the article , but these kids have a IGF dificiency, meaning they can't make IGF-1, and have normal/elevated GH levels but no igf.

Hmmm, how can the liver not produce IGF-1 if there is enough GH present? I mean, I'm sure these kid's are not the size of infants? They have grown but they are behind on average. That proves the liver does produce IGF-1. I wonder if they tried GH therapy on some of these kids first? From what I've read GH therapy pretty much works all of the time. I don't know, maybe these kid's liver just don't produce enough IGF-1 like they say. I still think GH therapy makes a lot more since for linear growth. It just seems IGF-1 would be too inconsistent with the risk of sides if the dosage is too high. Mainly blood glucose levels at such a young age as the body is developing. I would think there would be a risk of type 1 diabetes early in life? What the hell do I know, I'm not a doctor. I just read a lot of abstracts and BS on the net.

[graeme87]

"This drug will be useful for a very small number of patients," Kaplowitz said, adding it "will not work as growth hormone in most patients" with growth problems.

i think that says it all. GH is still the best way to go for height growth in most cases.