Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS I and II Studies for Multiple Sclerosis

 Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS I and II Studies for Multiple Sclerosis

Novartis’ Cosentyx (secukinumab) Receives NMPA’s (CFDA) Approval for Patients with Plaque Psoriasis in Adults

Shots:

  • The P-III ASCLEPIOS I and II (NCT02792218 and NCT02792231) studies involve assessing of Ofatumumab (20mg, SC, monthly) vs Aubagio (teriflunomide, 14mg, qd) in 1,882 patients with MS aged 18-55yrs. across 37 countries
  • The P-III ASCLEPIOS I and II studies resulted in meetings their 1EPs & 2EPs i.e, @30mos. reduction in annualized relapse rate evaluated by ARR & delayed time to disability progression, @6mos. confirmed disability improvement respectively, additional 2EPs will be presented at ECTRIMS
  • Ofatumumab is mAb targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion with its expected initiation of regulatory submission in H2’19. In Dec’2015, Genmab granted rights for ofatumumab in all indications including MS to Novartis

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