Asklepion secures US OK for Cholbam; wins peds voucher
This article was originally published in Scrip
Executive Summary
The luck of the Irish was with Baltimore, Maryland-based Asklepion Pharmaceuticals, which not only won US approval of Cholbam (cholic acid) on 17 March for two indications, but also was granted a rare pediatric disease priority review voucher, which is good for a priority review on a subsequent application that would not have otherwise qualified for priority review.