News Contact Us

Ofatumumab shows better efficacy versus Teriflunomide in RMS studies

Author : Paroma Bhattacharya | Published Date : 2019-08-31 
  • Head to head Phase III ASCLEPIOS studies I & II of OMB157 (ofatumumab) have revealed considerable superiority in reducing the ARR (annualized relapsed rate) in patients suffering from RMS (relapsing forms of multiple sclerosis) in comparison with terinuflomide.
  • OMB157 also met the secondary key endpoints of delaying time to confirmed progression of disability.
  • Ofatumumab safety profile was in keeping with the Phase II results, delivering sustained effectiveness.

Danish biotechnology expert Genmab A/S has reportedly announced Novartis’ positive results for OMB157 (ofatumumab) observed from the ASCLEPIOS I & II studies in Phase III. The studies, conducted to test the effectiveness and safety of monthly ofatumumab 20g (administered subcutaneously) vs once-daily teriflunomide 14g (administered orally) in adult patients with relapsing multiple sclerosis forms (RMS), showed that both treatments met primary endpoints, with ofatumumab showing profound and clinically significant reduction in confirmed relapse numbers, assessed as the ARR.

Key secondary endpoints for delay in time to confirm disability progression were met as well.

According to Genmab CEO, Jan van de Winkel, PhD, the information gathered through these studies indicates a potential turning point for ofatumumab and reinforces the belief that, if approved, it could become the 1st subcutaneously administered B-cell therapy for RMS, which patients can self-administer. He further expressed Genmab’s anticipation for the authorities’ feedback and delight for this new stage in the development of ofatumumab.

Novartis, that carries the right to develop and market of atumumab licensed by Genmab, has started plans to begin submissions to health authorities by the end of the year, on the basis of data collected during the ASCLEPIOS studies.

Phase III ASCLEPIOS I & II study results will be presented on the 13th of September in a late-breaker presentation format, at the esteemed 35th Congress of the ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis). The event is expected to take place from 11th to 13th September 2019, in Stockholm.

Source Credit: https://www.globenewswire.com/news-release/2019/08/30/1908824/0/en/Ofatumumab-Demonstrates-Superiority-Versus-Teriflunomide-in-Two-Head-to-Head-Phase-III-Multiple-Sclerosis-Studies.html


About Author

Paroma Bhattacharya

Paroma Bhattacharya

Paroma Bhattacharya, having completed her post-graduation in Journalism and Mass Communication, started her career in writing with resourceful and informative content development across diverse fields. Having dealt in myriad topics ranging from business to real estate, she now pens down articles for fractovia.org and other portals. She can be contacted at- [email protected] | https://twitter.com/paromab1

Related News

LVMH discusses a potential takeover of Tiffany for $14.5 billion

Published Date: 2019-10-29         Author: Paroma Bhattacharya

LVMH, one of the biggest luxury goods conglomerates in the world recently revealed that it is planning a takeover of the American luxury jewelry company, Tiffany & Co. Both the companies confirmed in separate statements that a takeover bid is being reviewed and a price of nearly $14.5 billion is... Read More

MariMed expands its presence by signing a licensing deal with Tropizen

Published Date: 2019-10-26         Author: Paroma Bhattacharya

Marijuana has always been classified as a Schedule I drug in the U.S., putting it in the same category as ecstasy, heroin and LSD, with an argument that it is a substance that can be abused and lacks medical value. But recent reports have revealed that Cannabis contains many medicinal properties ... Read More

MarginEdge raises $5M in Series A round led by Osage Ventures, IGC

Published Date: 2019-10-25         Author: Paroma Bhattacharya

The new investment will help MarginEdge form new alliances and expand geographically   This has boosted MarginEdge’s valuation to $10.4 million, the highest since its launch in 2015 Restaurant software platform developer MarginEdge has reportedly managed to raise $5 million in... Read More

© 2020 Fractovia. All Rights Reserved