Neurologists Anticipate FDA Approval of Ocrevus as 1st Progressive MS Treatment, Survey Finds

Neurologists in the U.S. expect — or, at least, highly anticipate — that Ocrevus (ocrelizumab), being developed by Roche as a treatment for both relapsing and progressive multiple sclerosis (MS), will be approved by year’s end, and a sizable number plan on quickly prescribing it, according to a recent update by  Spherix Global Insights  in “RealTime Dynamix: Multiple Sclerosis,” a quarterly report based on responses from over 100 neurologists actively treating MS patients.

Ocrevus is an anti-CD20 monoclonal antibody that targets mature B-cells. It is believed that these CD20-positive B-cells target axons and myelin sheaths of healthy neurons, triggering a cascade of immune reactions that lead to MS and disability.

The treatment has been seen in preclinical work to  bind to specific B-cells with CD20 markers but not to stem cells and plasma cells, preserving important immune functions in patients. In a Phase 3 study in progressive (ORATORIO, NCT01194570) MS patients it was reported to significantly reduce clinical disease progression, and in Phase 3 studies in relapsing patients (OPERA I and II, NCT01412333) that compared Ocrevus to Rebif (interferon-beta), the treatment was seen to both reduce relapses and significantly delay clinical disability.

In February, the U.S. Food and Drug Administration designated Ocrevus a “breakthrough therapy” as a potential primary progressive MS (PPMS) treatment, and a final FDA decision regarding its approval is expected by year’s end.

According to the third quarter “Real Time Dynamix” report, more than one-third of responding neurologists said they  intend to prescribe Ocrevus to patients, particularly those with PPMS, soon after it reaches the market. (If approved to treat progressive MS, Ocrevus will be the first treatment indicated for this patient group. The survey suggests it will grab much of PPMS market now using Rituxan (rituximab) off-label.)

Among relapsing MS (RMS) patients, Ocrevus may well challenge other infusion treatments, like Biogen’s Tysabri (natalizumab) or Sanofi/Genzyme’s Lemtrada (alemtuzumab), a press release on the report stated. About 15 percent of the survey neurologists spoke of “significant interest” among RMS patients regarding the potential therapy.

But Ocrevus, an intravenous treatment, itself could itself be challenged by advances in the MS field, the report said, particularly the move toward oral disease modifying therapies (DMTs), like Biogen’s Tecfidera (dimethyl fumarate), Novartis’ Gilenya (fingolimod), and Sanofi-Genzyme’s Aubagio (teriflunomide). Aubagio, particularly, has been gaining in interest among patients decreasing their use of Gilenya and Tecfidera because of safety concerns, surveyed neurologists reported.

Regarding injectable drugs, Teva’s Copaxone (glatiramer acetate) is still leading the charts, the report revealed, despite some competition from Sandoz’s Glatopa (glatiramer acetate) — the first generic DMT to enter the MS market. Even though 24% of the neurologists said Copaxone use had decreased in the past three months, the brand is still firmly entrenched.

The survey also showed that, although overall share projections are down for Bayer’s Betaseron (interferon beta-1b), the introduction of the Betaconnect auto-injector device revitalized the brand for some neurologists, highlighting the importance of innovative solutions for existing treatments in what has become “a very crowded market.”