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Igf fda aproved!
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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.
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.
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Pumpin'
Ripped Bodybuilder
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Xtreme_BODY zei:
Voor BB-ers is dat een downside ja.. maarja wij hebben toch Nutral
Als ik mijnkind straks nu elke week een paar shtjes igf geef, wordt hij waarschijnlijk dus een reus
Btw: MC?
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Pumpin' zei:Voor BB-ers is dat een downside ja.. maarja wij hebben toch Nutral
Als ik mijnkind straks nu elke week een paar shtjes igf geef, wordt hij waarschijnlijk dus een reus
Btw: MC?
Moet ze hier ook alles vertellen
Muscle Chemistry
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