FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time

The U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated the application for a two-hour Ocrevus® (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).

FDA Approves Zeposia (Ozanimod), Oral Therapy for All with Relapsing MS

The U.S. Food and Drug Administration (FDA) has approved Zeposia (ozanimod) oral capsules to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS).

Due to the COVID-19 pandemic, however, when it will arrive in clinics for patient use is not yet known, Bristol Myers Squibb (BMS), which will market Zeposia, said in a press release announcing the approval.

Washington, D.C. (May 9, 2019) — Reinforcing the biopharmaceutical industry’s commitment to providing patients with more transparency about medicine costs, Pharmaceutical Research and Manufacturers of America (PhRMA) member companies today announced the launch of the Medicine Assistance Tool, or MAT. The new platform provides patients with links to websites, referenced in company direct-toconsumer (DTC) television advertising, where information about the cost of the prescription medicine is available. MAT also helps patients find financial assistance programs.


Positive Late-Breaking Phase II Data Evaluating Investigational Oral Therapy, Evobrutinib in RMS

ROCKLAND, Mass, October 12, 2018 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the 24-week results of the double-blind, randomized, placebo-controlled, 48-week, Phase II study of evobrutinib in patients with relapsing multiple sclerosis (RMS) at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS) in Berlin, Germany. In this study, dimethyl fumarate (240mg BID) represented an open-label reference arm, and there were no formal statistical comparisons between dimethyl fumarate and evobrutinib or placebo. The study met its primary endpoint, with evobrutinib 75mg QD (once-daily) and 75mg BID (twice-daily) significantly reducing the number of gadolinium enhancing T1 (T1 Gd+) lesions measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo. Evobrutinib is a highly-specific, oral Bruton’s Tyrosine Kinase (BTK) inhibitor and the first BTK inhibitor to show clinical proof-of-concept in relapsing MS.

“We are among the first to evaluate a BTK inhibitor for chronic autoimmune diseases, and we continue to be highly encouraged by the results we’ve seen in patients with relapsing MS thus far,” said Luciano Rossetti, Global Head of Research & Development at EMD Serono. “Evobrutinib was discovered in-house and is an example of the innovation coming from our own labs. We have a long history of delivering innovative solutions with the aim of advancing MS care, and look forward to further exploring the potential of evobrutinib in future clinical trials.”


TG Therapeutics, Inc. Announces Final Phase 2 Multiple Sclerosis Data Presentation at the 34th Congress of ECTRIMS

NEW YORK, Oct. 11, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the final results from the Phase 2 multicenter trial of ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS). The data is being presented today during an oral session at the 34thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), in Berlin, Germany. Highlights from the presentation are outlined below.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased by the final Phase 2 MS data presented today during the annual congress of ECTRIMS. We believe this complete dataset, which now includes all patients through 48 weeks, confirms the efficacy and safety profile of ublituximab and provides a compelling rationale for its use to treat patients with MS. This final data compare very favorably with previously presented data for ocrelizumab, the only approved anti-CD20 for the treatment of MS. With more than 1 million patients currently living in the United States with MS, we believe ublituximab will become an important treatment option, representing a major market opportunity for us.” Mr. Weiss continued, “These data support our fully enrolled global Phase 3 ULTIMATE program, being conducted under SPA agreement with the FDA, which if successful would support the full approval of ublituximab in relapsing forms of MS.”


OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression over Five Years in Relapsing and Primary Progressive Multiple Sclerosis

  • People with relapsing MS (RMS) treated sooner with OCREVUS had earlier reduction in disease activity and less disability progression vs. those who switched from interferon beta-1α
  • People with primary progressive MS (PPMS) treated with OCREVUS earlier had less disability and upper limb progression than those who switched from placebo
  • Longer-term safety data are consistent with OCREVUS’ favorable benefit-risk profile for both RMS and PPMS
  • OCREVUS approved in 68 countries, with over 70,000 patients treated globally

  • South San Francisco, CA -- October 9, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS® (ocrelizumab) data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 10-12 in Berlin, Germany. Five-year data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO show OCREVUS efficacy is maintained on key measures of disease activity and that people treated earlier with OCREVUS had superior disability progression outcomes compared with RMS patients who switched from interferon beta-1α or PPMS patients who switched from placebo.


    New Efficacy and Safety Data on MS Portfolio to be Presented at ECTRIMS 2018

  • Late-breaking Phase II primary endpoint data for investigational therapy evobrutinib, the first oral BTK inhibitor to show clinical proof-of-concept in RMS
  • Up to 10 years of patient experience provides further insight into the benefit-risk profile of investigational cladribine tablets
  • Late-breaking data from multi-sponsored European IFNβ Pregnancy Registry highlight Rebif safety outcomes during pregnancy
  • A total of 23 abstracts for cladribine tablets, Rebif and evobrutinib will be presented at ECTRIMS 2018

  • ROCKLAND, Mass, October 8, 2018 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that it will present data from approved and investigational multiple sclerosis (MS) treatments from its neurology and immunology portfolio at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS), taking place from 10–12 October 2018, in Berlin, Germany. EMD Serono will present 23 abstracts, including new safety and efficacy data on investigational cladribine tablets, Rebif® (interferon beta-1a) and investigational therapy evobrutinib, a highly-specific, oral Bruton’s Tyrosine Kinase (BTK) inhibitor.

    Key cladribine tablets data will include:

  • An updated integrated safety analysis of patients from the CLARITY, CLARITY Extension and ORACLE-MS trials, including two additional years of data from the long-term PREMIERE Registry (up to 10-years of follow-up).
  • An overview of the first six months of real-world evidence safety data on cladribine tablets.
  • Results from a post hoc analysis of the CLARITY study will characterize relapse severity and frequency in relapsing-remitting MS (RRMS) patients in cladribine tablets versus placebo.
  • New data from post hoc analyses to support the duration of effect of cladribine tablets across patient subgroups of different ages and with different disease activity status (in Years 3 and 4 post-treatment) will be presented.


    Novartis announces FDA filing acceptance of siponimod (BAF312), the first and only oral drug shown to delay disability progression in typical SPMS patients

  • There is a critical need for safe and effective treatments for secondary progressive multiple sclerosis (SPMS), a highly debilitating form of MS characterized by gradual, irreversible worsening of disability, largely independent of relapses
  • If approved, siponimod (BAF312) would be the first oral disease modifying therapy with the potential to delay progression for SPMS patients
  • Filing is supported by the Phase III EXPAND data, which showed siponimod had beneficial effects on disability, relapses and MRI disease activities in typical SPMS patients[1]
  • Novartis used a priority review voucher to expedite review of siponimod in the US to ensure patients could benefit from the drug as soon as possible, pending approval

  • EAST HANOVER, N.J., Oct. 8, 2018 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults. This phase of multiple sclerosis (MS) can substantially impact lives, due to vision impairment, fatigue, dependence on walking aids and inability to work2. To bring this treatment to the MS community as quickly as possible, Novartis used a priority review voucher to expedite the review of siponimod. Regulatory action for siponimod is anticipated in March of 2019.

    More than 80% of people with relapsing-remitting MS (RRMS) – the most common form of the condition at diagnosis – go on to develop SPMS, with or without relapses2,3. SPMS is a form of MS that leads to progressive, irreversible disability, such as the need for enhanced walking aids and wheelchairs, bladder dysfunction and cognitive decline, largely independent of relapses. Following the initial RRMS course, there is a gradual increase in the number of patients transitioning to SPMS, with around 25% progressing by 10 years post-onset, 50% by 20 years and more than 75% by 30 years2,3.