FDA approves CSL's Haegarda for HAE

FDA approved Haegarda (CSL830) from CSL Ltd. (ASX:CSL) to prevent hereditary angioedema in adolescent and adult patients. The agency said Haegarda, which has Orphan Drug status, is the first subcutaneous complement 1 (C1) esterase inhibitor it has approved to treat a rare genetic disease.

FDA based its approval on data from the Phase III COMPACT trial in Type I or II HAE patients. Compared with placebo, both doses of Haegarda met the primary endpoint of reducing the mean number of time-normalized HAE attacks per month...