Tags : OMB157

The US FDA Extends Review of sBLA of Ofatumumab (OMB157)

Shots: Novartis reported that the US FDA has extended its review of sBLA for ofatumumab (OMB 157) to treat patients with RMS. The company anticipates the regulatory action in Sept’2020 Novartis works with the US FDA to continue the review for ofatumumab (SC) in RMS, for the approval in the US with expected EU approval […]Read More

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS I

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 […]Read More