The US Food and Drug Administration (FDA) has approved Novartis’ relapsing multiple sclerosis (MS) treatment Kesimpta, one of the company’s most promising growth drivers as identified by CEO Vas Narasimhan.
The approval is 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.
The drug is already approved for the treatment of chronic lymphocytic leukaemia (CLL), with the clinical development programme in relapsing MS taking ten years from the initiation of early studies to achieving regulatory approval.
Kesimpta’s approval in relapsing MS builds on Novartis’ existing presence in the therapy area, which includes its active secondary progressive multiple sclerosis (SPMS) therapy Mayzent (siponimod).
However, the drug will have fierce competition in the market, from rivals such as Roche’s Ocrevus (ocrelizumab) and Sanofi’s Aubagio, despite touting superior efficacy data over the latter.
Both Kesimpta and Ocrevus selectively target the immune system’s CD20-positive B cells that image nerve tissue and cause disease progression. Roche’s drug is also the only drug approved for the treatment of primary progressive MS, so it will be a tough competitor for Novartis to take on.
Last May, Novartis’ chief exec Narasimhan identified Kesimpta as one of the company’s potential blockbusters in its emerging pipeline. Following the FDA approval, Novartis has posted a list price for the drug of $83,000, with the added advantage that it is the only drug for relapsing MS that can be self-administered at home.
“Multiple sclerosis (MS) is a complex disease, and response to disease modifying treatment will vary among individuals,” said Bruce Bebo, executive vice president of research at the US National MS Society.
“This makes it important to have a range of treatments available with different mechanisms of action and routes of administration. We are pleased to have an additional option approved for the treatment of relapsing forms of MS,” he added.
Novartis expects Kesimpta to be available in the US in early September, and is expecting regulatory approval in the EU by the second quarter of 2020.