Af­ter rocky hep C path, Achillion finds sur­er foot­ing with FDA break­through sta­tus

Achillion’s promis­ing proof-of-con­cept da­ta for its lat­est drug has won break­through sta­tus at the FDA.

The US reg­u­la­tor grant­ed its cov­et­ed des­ig­na­tion to dan­i­co­pan as a treat­ment for ane­mia in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria pa­tients tak­ing the main­line C5 in­hibitor treat­ment Soliris. Up to 75% of PNH pa­tients suf­fer from ane­mia even af­ter treat­ment, ac­cord­ing to Achillion, with up to a third re­quir­ing blood trans­fu­sions in the past year.

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