Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Con­cert Phar­ma­ceu­ti­cals’ path to de­vel­op­ing a drug that treats alope­cia area­ta has been bumpy, but the phar­ma com­pa­ny scored a win Wednes­day.

The FDA grant­ed Con­cert a Break­through Ther­a­py Des­ig­na­tion (BTD) for its oral Janus ki­nase in­hibitor, named CTP-543, paving the way for a Phase III study of the drug to be­gin in the fourth quar­ter of 2020. The news fol­lows pos­i­tive Phase II re­sults from last Sep­tem­ber, which saw the drug meet its pri­ma­ry end­point in both 8 mg and 12 mg twice-dai­ly dos­es.

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