Gen­fit wins BTD sta­tus at FDA for its lead drug for liv­er dis­ease; Idor­sia out­lines $530M '19 spend­ing plans on late-stage R&D

→ Gen­fit $GN­FT is get­ting a help­ing hand from the FDA with its lead drug elafi­bra­nor, in de­vel­op­ment for pri­ma­ry bil­iary cholan­gi­tis, a liv­er dis­ease of­ten re­ferred to as PBC. The agency has hand­ed over its break­through ther­a­py des­ig­na­tion for the drug, aim­ing at keep­ing the reg­u­la­to­ry doors open as re­searchers look to hus­tle it through de­vel­op­ment. “The FDA’s de­ci­sion to grant elafi­bra­nor the Break­through Ther­a­py Des­ig­na­tion on the ba­sis of our Phase II da­ta, is of course a mile­stone that will al­low us to ac­cel­er­ate elafi­bra­nor’s de­vel­op­ment,” not­ed deputy CMO Pas­cal Bir­man.

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