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Re: rkrw post# 84900

Monday, 10/12/2009 11:45:17 AM

Monday, October 12, 2009 11:45:17 AM

Post# of 257257
The label is weird. As far as I know, C1-Inhibitor concentrate is an effective therapy that rapidly relieves acute swelling attacks at any body location in patients with HAE. Makes sense the FDA wants 2 products in the market but I don't have a clue regarding the narrow label.

Edit: Found the reason to the weird label- Inclusion Criteriain CLS phase III trial

* Documented congenital C1-INH deficiency
* Acute facial or abdominal HAE attack

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