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Replies to #84900 on Biotech Values
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genisi

10/12/09 11:45 AM

#84904 RE: rkrw #84900

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