Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)
[caption id="attachment_9277" align="aligncenter" width="1079"] Press Release[/caption]
- Filings are supported by?Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as annualized relapse rate (ARR)1
- Ofatumumab is a novel B-cell therapy that delivers sustained efficacy with a favorable safety profile1
- If approved, ofatumumab has the potential to become a first-choice treatment for a broad RMS population and the first B-cell therapy that can be self-administered at home using an autoinjector pen
- Regulatory approval for ofatumumab in the US is expected in June 2020 and in Europe by Q2 2021
- Reduced the ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) (p<0.001 in both studies) in ASCLEPIOS I and II respectively1
- Showed highly significant suppression of both Gd+ T1 lesions and new or enlarging T2 lesions, demonstrating a profound abrogation of new inflammatory activity1
- Showed a relative risk reduction of 34.4% (p=0.002) in three-month CDP and 32.5% (p=0.012) in six-month CDP in pre-specified pooled analyses1