Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports

Prescriptions of Roche’s Ocrevus (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching a disease-modifying therapy (DMT) continue to rise in Europe, according to a survey conducted by Spherix Global Insights.

Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein, was approved in the European Union to treat active forms of relapsing MS and primary progressive MS (PPMS) — for which there were no approved treatments — in January 2018.

However, the recent approval of Novartis’s Mayzent (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosis (SPMS), and the potential approval of ofatumumab (by Novartis and Genmab) for relapsing forms of MS may threaten Ocrevus’s position as “one of the most preferred DMTs” on the continental market, a press release summarizing the report noted.

Results of the online survey, sent to 247 neurologists in France, Germany, Italy, Spain, and the U.K. less than a month after Mayzent’s approval, were detailed in the newest bi-annual report “RealTime Dynamix: Multiple Sclerosis (EU).” The survey looked into trends regarding DMT use and future expectations.

Findings confirmed that the introduction of Ocrevus, Merck KGaA’s Mavenclad (cladribine) — an oral induction therapy for active relapsing MS — and Mayzent have contributed to the recent growth in DMT use rates for relapsing-remitting MS (RRMS), active SPMS, and PPMS. In induction therapy, an aggressive approach with a highly effective agent is given to newly diagnosed patients as their first treatment.

Notably, Ocrevus “has shown tremendous ability to usurp historical mainstays,” and an “impressive and sustained” growth among patients initiating or switching DMTs, Spherix noted in the release.

Data showed that the therapy replaced glatiramer acetate — sold by Teva under the brand name Copaxone and more recently in bioequivalent generic versions — as one of the most widely used DMTs on the market.

Glatiramer acetate, which is frequently the first choice for RRMS treatment due to its favorable safety profile, is given through under-the-skin injections.

While the introduction of generic, less costly versions could have lessened the drop in glatiramer acetate use, Teva’s success with patent litigation and continued physician loyalty toward Copaxone minimized these effects, the report noted. This also suggests that the earliest generic versions of Copaxone are struggling to gain a foothold.

Among patients initiating a DMT for the first time, Biogen’s Tecfidera (dimethyl fumarate) and Sanofi Genzyme’s Aubagio (teriflunomide) are currently the ones most commonly prescribed. This was found to be associated with neurologists’ preference for the convenience associated with oral DMTs, especially in France.

But Ocrevus is becoming an increasingly popular treatment option for these patients, since many neurologists favor the use of induction treatment. Particularly in the U.K., where induction treatment is common, the growth in Ocrevus use as first DMT was accompanied by a corresponding drop in Tecfidera use, threatening its dominance in early lines of therapy.

Data also revealed that Ocrevus became the most prescribed therapy among patients switching their DMT.

According to a Spherix report published last August, Novartis’ Gilenya (fingolimod), Aubagio, and Biogen’s Tysabri (natalizumab) and Tecfidera were the top switch-to DMTs in Europe. The new report shows that Tecfidera, in particular, had a substantial drop in use in France and Germany.

Prescriptions and overall preference for Sanofi-Genzyme’s Lemtrada (alemtuzumab) also fell significantly, which would be expected after restrictions on its use were recommended by the European Medicines Agency (EMA) in November 2019.

Lemtrada’s prescriptions appear to have been replaced by those of Ocrevus, especially in Germany, Italy, and Spain.

Ocrevus successful growth to date, however, may be threatened in the future by the recently approved Mayzent and the potential approval of ofatumumab, the report stated.

While Bayer’s Betaseron (interferon beta 1b) is also specifically indicated for active SPMS, neurologists expect that Mayzent’s true competition will be with Ocrevus — which was previously found to be the top switch-to DMT in active SPMS patients in Europe.

More than half of the neurologists stated that they were extremely willing to prescribe Mayzent to a patient with active SPMS, suggesting that it may become a key therapeutic option for these people.

Diagnoses of active SPMS are also expected to increase considerably over the next two years, the report noted, highlighting that neurologists plan to reclassify a proportion of their RRMS patients as having active SPMS in order to make them eligible for Mayzent.

Ofatumumab — currently under regulatory review for possible approval in the U.S. and Europe — is an anti-CD20 antibody (like Ocrevus) that can be self-administered under the skin using an autoinjector pen.

While the EMA’s decision is not expected until next year, those neurologists surveyed expressed high hopes for its effectiveness (expected to be comparable to that of Ocrevus), and its convenient at-home administration. A neurologist in Germany stated that ofatumumab is a “highly effective therapy concept with better controllability than [Ocrevus].”

However, neurologists also noted that they are accustomed to patient monitoring and associated treatments that require administration in a clinic or hospital, such as Ocrevus. “In reality, candidacy for ofatumumab may depend heavily on [the] likelihood of good patient compliance and adherence,” the report emphasized.

Spherix noted that its next “RealTime Dynamix: Multiple Sclerosis (EU)” report will assess the impact of a DMT’s dosing profile when selecting a new therapy to switch to, and Mayzent’s early performance in the active SPMS market and against current preferred DMTs for this patient population.