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Novartis’ MS therapy Kesimpta reduces risk of disability progression regardless of relapses

New post hoc data comes from phase 3 ASCLEPIOS trials

Novartis has revealed new post hoc data for its multiple sclerosis (MS) therapy Kesimpta only a few weeks after the drug received approval from the European Commission.

New analysis from the phase 3 ASCLEPIOS trials found that Kesimpta (ofatumumab) cut the risk of disability progression independent of relapse activity (PIRA) by up to 60% at three and six months when compared to Sanofi’s Aubagio (teriflunomide) in a subgroup of newly diagnosed, treatment-naive patients with relapsing multiple sclerosis (RMS).

The PIRA analysis also showed that over 50% of disability worsening events experienced by newly diagnosed and treatment-naive RMS patients occurred regardless of whether they also experienced relapses.

“Kesimpta reduced this risk of progression by up to almost 60% versus teriflunomide, reinforcing the importance of early intervention with high-efficacy treatment to address underlying disease progression before irreversible damage occurs,” commented Jacqueline Nicholas, system chief neuroimmunology & MS, OhioHealth MS Center, Riverside Methodist Hospital in the US.

“Evidence shows that progression occurs in people living with MS in the early stages of disease. This reinforces the need to treat early with a first-choice treatment like Kesimpta, which combines powerful efficacy with a favourable safety profile and can be self-administered at home,” added Estelle Vester-Blokland, global head neuroscience medical affairs, Novartis.

Kesimpta was approved in the EU for the treatment of RMS in adults with active disease at the end of March.

The approval was based on results from the phase 3 ASCLEPIOS I and II studies, in which Kesimpta (ofatumumab) demonstrated superiority over Sanofi’s Aubagio (teriflunomide) in reducing the number of confirmed relapses in patients with relapsing forms of MS.

Kesimpta also met the key secondary endpoints, which included delaying time to confirmed disability progression, in the head-to-head study.

In the US, Kesimpta is also approved for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in adults.

The CD20 monoclonal antibody (mAb) was originally developed by Danish biotech company Genmab, and subsequently developed and marketed worldwide by Novartis under a licence agreement.

According to Genmab, Kesimpta is the first B-cell therapy that can be self-administered at home using Novartis’ Sensoready autoinjector pen.

Article by
Lucy Parsons

16th April 2021

From: Research



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