J&J's head-to-head PhI­II da­ta promise drug launch in­to crowd­ed MS mar­ket

J&J an­nounced pos­i­tive da­ta from a head-to-head Phase III tri­al squar­ing their S1P1 MS drug pones­i­mod against Sanofi’s Auba­gio, set­ting up an FDA fil­ing lat­er this year and a pos­si­ble 2020 launch in­to an in­creas­ing­ly crowd­ed space.

A J&J launch will fly against steep head­winds. No­var­tis’s Mayzent (sipon­i­mod), tabbed by CEO Vas Narasimhan as a po­ten­tial block­buster, gained FDA ap­proval in March based off a place­bo study. The same month, Cel­gene re-filed its FDA ap­pli­ca­tion for ozan­i­mod, lever­ag­ing da­ta from a head-to-head tri­al against Avonex. And in Au­gust, TG Ther­a­peu­tics an­nounced pos­i­tive re­sults from its Phase II study of ubli­tux­imab, and No­var­tis an­nounced pos­i­tive re­sults from their oth­er MS drug Arz­er­ra (ofa­tu­mum­ab) in its head-to-head tri­al against Auba­gio.

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