Press Release | MAY 2021
Bristol Myers Squibb is conducting a Phase 3b Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod. The study is actively enrolling subjects within USA and Canada. Subjects ages 18 to 65 who have had relapsing MS for 5 years or less, and have been treated with < 1 Disease-Modifying Therapy at time of study entry may qualify to participate.
For more information on this trial, please refer to BMS Study Connect.
Press Release | FRIDAY, MARCH 19, 2021
Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J., March 19, 2021 /PRNewswire/--The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.3,4,5
The FDA approval is based, in part, on a two-year, head-to-head Phase 3 clinical trial in which PONVORY™ 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide (Aubagio®) 14 mg in patients with relapsing MS.3 Over the study period, 71% of patients treated with PONVORY™ had no confirmed relapses, compared to 61% in the teriflunomide group.3 PONVORY™ was also superior to teriflunomide in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively.3 GdE T1 lesions and T2 lesions are identified using magnetic resonance imaging (MRI) technology and are recognized as classic measures of MS pathology that can provide insights into disease activity and disease burden, respectively.6,7
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Press Release | MONDAY, JUNE 1, 2020
Bristol Myers Squibb Announces Commercial Launch and Availability of ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that ZEPOSIA® (ozanimod) 0.92 mg, a new once-daily oral medication for adults for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, is now commercially available in the U.S. ZEPOSIA was approved by the U.S. Food and Drug Administration (FDA) on March 25, 2020.1
*ZEPOSIA is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers appropriate RMS patients an initiation with no genetic test and no first dose observation.1,2,3 An up-titration scheme should be used to reach the maintenance dosage of ZEPOSIA, as a transient decrease in heart rate and atrioventricular conduction delays may occur.1 Before initiation of treatment with ZEPOSIA, all patients require assessments including a recent complete blood count including a lymphocyte count (within six months or after discontinuation of prior MS therapy), an ECG to determine whether preexisting conduction abnormalities are present, a recent liver function test (within six months), and consideration of current and prior medications, including vaccinations.1 For patients with a history of uveitis or macular edema, an ophthalmic assessment is required.1
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Rebif® U.S. Label Now Includes Pregnancy Outcomes and Lactation Information to Help Inform Treatment Decisions for Women with MS
- Label update is based on data from a large register-based study, as well as other published studies over several decades
- Multiple sclerosis (MS) is a chronic disease affecting twice as many women as men and often is diagnosed during women's childbearing years(1)
- Pregnancy is a key treatment consideration as more than 50 percent of female patients with relapsing MS are of childbearing age(2)
ROCKLAND, Mass., May 27, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today the U.S. Food and Drug Administration (FDA) has approved the inclusion of new safety data on pregnancy and breastfeeding in the prescribing information for Rebif® (interferon beta-1a), in accordance with the FDA's Pregnancy and Lactation Labeling Rule (PLLR). With a safety profile supported by 20+ years of combined clinical trial data and real-world patient experience, Rebif is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.3
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New Late-Breaking Data at EAN Indicate Evobrutinib is the First BTK Inhibitor to Report Efficacy and Safety in MS Over 108 Weeks
- Investigational evobrutinib is the first and only Bruton's Tyrosine Kinase inhibitor to demonstrate high and sustained efficacy through 108 weeks in clinical studies
- No new safety signals identified in the 60 week open-label extension, consistent with data seen in more than 1,200 patients who have received evobrutinib to date, across MS and other conditions
- Late-breaking data presented as part of the European Academy of Neurology (EAN) Virtual Congress
ROCKLAND, Mass., May 23, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced data on the long-term efficacy and safety profile of evobrutinib, an investigational, oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS). The results from the Phase II open-label extension (OLE) study will be presented as a late-breaker at the European Academy of Neurology (EAN) 2020 Virtual Congress.
"These data demonstrate evobrutinib has a sustained and high impact on annualized relapse rate over 108 weeks," said Luciano Rossetti, Head of Global Research & Development for EMD Serono. "Greatest efficacy was clearly associated with BTK occupancy, and this further validates our choice of dose for the Phase III program. We are also encouraged by evobrutinib's breadth of consistent safety data, including no increase of serious infections in more than 1,200 patients up to two years."
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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).
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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.
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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.
CLICK HERE TO VIEW COMPLETE PRESS RELEASEPositive 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.”
CLICK HERE TO VIEW COMPLETE PRESS RELEASETG 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.”
CLICK HERE TO VIEW COMPLETE PRESS RELEASEOCREVUS (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.
CLICK HERE TO VIEW COMPLETE PRESS RELEASENew 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.
CLICK HERE TO VIEW COMPLETE PRESS RELEASENovartis 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 relapses
2,3. 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 years
2,3.
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