J&J bids for EU OK on Leg­end CAR-T; FDA ex­tends re­view pe­ri­od for Arde­lyx's phos­pho­rus con­trol drug

J&J may be on its way to its first cell ther­a­py ap­proval on two con­ti­nents.

The big phar­ma an­nounced on Fri­day that they had ap­plied for the EU to ap­prove the CAR-T ther­a­py for mul­ti­ple myelo­ma they are co-de­vel­op­ing with Nan­jing-based Leg­end Biotech. The ther­a­py is now sit­ting be­fore reg­u­la­tors in both Eu­rope and the US, where J&J start­ed a rolling sub­mis­sion in Jan­u­ary.

The ap­pli­ca­tions put the CAR-T on track to com­plete a me­te­oric rise to mar­ket next year and com­pete with a ri­val ther­a­py from blue­bird bio and Bris­tol My­ers Squibb that goes af­ter the same can­cer re­cep­tor, BC­MA, but has shown sig­nif­i­cant­ly worse ef­fi­ca­cy in clin­i­cal tri­als.

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