Mission successful for Novartis after FDA approves ofatumumab in MS

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It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed.

The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

Kesimpta will have a list price of around $83,000 a year, which the company argues will make it one of the lowest-cost branded options in a highly competitive market where drugs like Sanofi’s Aubagio and Roche’s Ocrevus have strong footholds.

Novartis is also talking up Kesimpta’s “favourable” safety profile and an injector pen that allows the drug to be administered each month at home.

The company hopes this will give it a competitive advantage over Roche’s Ocrevus (ocrelizumab), which is given as an infusion every six months in a hospital clinic after two starter doses two weeks apart.

Novartis also pointed to trial data showing better efficacy and similar safety profile when compared with Sanofi’s oral MS drug Aubagio (teriflunomide).

Ofatumumab was first approved by the FDA as a cancer drug in chronic lymphocytic leukaemia (CLL), under the brand name Arzerra, in 2014 when it was owned by GlaxoSmithKline.

But Novartis took control of ofatumumab in 2015 as part of an asset-swap deal, picking up rights to its other uses in autoimmune diseases such as MS, and has completed a research project lasting around 10 years to reimagine the drug as a treatment for MS.

Patients taking the drug for CLL in the US will be transitioned over to an access programme at no cost.

Novartis will pay co-developer Genmab a lump sum of $30 million as payment for lost royalties.

Kesimpta works by targeting B-cells, which are the underlying cause of both multiple sclerosis and several kinds of blood cancer including CLL.

Approval of Kesimpta is based on results from the phase 3 ASCLEPIOS I and II studies, in which it demonstrated superiority versus Aubagio in significantly reducing the annualised relapse rate, three-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.