Ocrevus and early start with aggressive treatment favored in US
Spherix Global Insights report on trends among neurologists working in MS
Neurologists in the U.S. are generally favoring more aggressive early treatment for multiple sclerosis (MS), according to an analysis by market research company Spherix Global Insights.
With over a dozen therapies available in the U.S. to treat relapsing forms of MS, patients and providers have options to choose from. As part of its monitoring of the MS pharmaceutical market, Spherix gauged neurologists’ satisfaction with these treatments.
Neurologists generally reported the highest satisfaction with Ocrevus (ocrelizumab). This anti-CD20 monoclonal antibody is administered twice yearly via an infusion into the bloodstream, and it works by destroying B-cells. Sold by Genentech (a Roche company), it is notably the only therapy approved to treat primary progressive multiple sclerosis (PPMS).
High satisfaction also was noted with Novartis’ Kesimpta (ofatumumab) and Biogen’s Tysabri (natalizumab), though these “both trail the satisfaction level observed with … Ocrevus,” according to Spherix.
Kesimpta, like Ocrevus, is an anti-CD20 monoclonal antibody, though it’s administered by subcutaneous (under-the-skin) injection once each month instead of a twice-yearly infusion.
Neurologists moving to embrace earlier use of high-efficacy treatments
A Phase 3 clinical trial (NCT05232825) is currently testing the approved infusion version of Ocrevus against a subcutaneous version of the therapy, with the aim of showing that the two formulations have equivalent efficacy.
If results are positive, the new formulation of Ocrevus “could join Kesimpta as another subcutaneously administered anti-CD20 agent,” Spherix noted.
A third anti-CD20 monoclonal antibody, TG Therapeutics’ Briumvi (ublituximab-xiiy), was recently launched in the U.S. after being approved to treat relapsing MS late last year. Like the currently approved version of Ocrevus, Briumvi is given via twice-yearly infusions, although infusions of Briumvi are given somewhat faster.
Before Briumvi’s approval, neurologists predicted that it would be taken up quickly by the MS community in the U.S., according to Spherix. It expected that the number of patients on Briumvi “could equal that of Kesimpta six months after launch.”
Spherix notes, however, that neurologists consider Briumvi and Ocrevus to be “largely comparable across attributes,” and “TG Therapeutics will need to demonstrate a compelling value proposition to drive use.” TG Therapeutics has touted the list price for Briumvi, $59,000 per year, as the lowest of available, brand-name MS therapies.
Sandoz and Polpharma Biologics are expected to soon launch a biosimilar version of natalizumab, the active agent in Tysabri. Biosimilars, designed to act in identical ways to a brand-name medication, are usually sold at lower prices than the original product. Tysabri, administered via monthly infusions, works by blocking immune cells from getting into the nervous system.
“Early data … indicates that neurologists already feel comfortable prescribing the biosimilar option to their MS patients, suggesting that sales of blockbuster Tysabri could be rapidly eroded,” according to Spherix.
Tysabri and the various anti-CD20 antibodies are all considered high-efficacy therapies for MS — medications that can powerfully suppress inflammatory activity to substantially reduce the rate of disease relapses. Because they work by potently suppressing the immune system, high-efficacy therapies also tend to carry a greater risk of side effects than older MS treatments.
The general shift in the MS market suggests overall that “neurologists [are moving] to embrace an earlier and more aggressive treatment approach,” Spherix reported.
Even with the many therapies currently available, the pipeline of investigational MS treatments “remains robust,” the company noted. A novel class of therapies called BTK inhibitors, which work to block B-cell activation, is “already of high interest to neurologists,” it stated.
Several pharmaceutical companies have experimental BTK inhibitors for MS in late stages of clinical testing. These investigational treatments include EMD Serono’s evobrutinib, Genentech’s fenebrutinib, Sanofi’s tolebrutinib, and Novartis’ remibrutinib.