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ROP — Roche Holding AG News Story

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Brief: Roche Says FDA Accepts Roche NDA For Fenebrutinib Under Priority Review

BRIEF-Roche Says FDA Accepts Roche NDA For Fenebrutinib Under Priority Review

- ROCHE HOLDING AG ROPC.S:

  • ROCHE’S FENEBRUTINIB IS THE FIRST BTK INHIBITOR TO RECEIVE U.S. FDA FILING ACCEPTANCE IN BOTH RELAPSING AND PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

  • FDA ACCEPTS ROCHE NDA FOR FENEBRUTINIB UNDER PRIORITY REVIEW

  • FENEBRUTINIB REDUCED RELAPSES BY 51% AND 58% VERSUS TERIFLUNOMIDE IN PHASE III RMS TRIALS

  • FENEBRUTINIB SLOWED DISABILITY PROGRESSION IN PHASE III PPMS TRIAL VERSUS OCREVUS

Source text: ID:nGNE3s24HB

Further company coverage: ROPC.S


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