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.

CLICK HERE TO VIEW THE COMPLETE ANNOUNCEMENT
The Centers for Disease Control and Prevention (CDC) are following the outbreak of coronavirus (COVID-19), which causes a respiratory disease. This is a rapidly evolving situation and questions regarding the use of MS disease modifying therapies during this outbreak are being raised.

The National MS Society’s National Medical Advisory Committee (NMAC) recommends the following:

  1. People with MS should follow CDC guidelines and these additional recommendations for people at risk for serious illnesses from COVID-19.

  2. People with MS should continue disease modifying therapies (DMTs) and discuss specific risks with their MS healthcare provider prior to stopping a DMT.

  3. Before starting a cell depleting DMT* or a DMT that carries warnings of potentially severe increase in disability after stopping**, people with MS and their MS healthcare providers should consider specific risks (e.g. age, comorbid health conditions, location) and benefits.


These recommendations are the expert opinion of the National Medical Advisory Committee and are based on their clinical experience and assessment of the limited data available regarding COVID-19 and MS DMTs. They have been endorsed by the Consortium of Multiple Sclerosis Centers (CMSC) and members of the MS Coalition***.

We are continuing to monitor this quickly evolving situation and these recommendations may be modified as more data becomes available.

* Cell depleting therapies include: Lemtrada, Mavenclad, Ocrevus and Rituxan (used off-label in MS)

** DMTs with a warning of potentially severe increase in disability after stopping include: Gilenya and Tysabri

*** Members of the MS Coalition include: Accelerated Cure Project for Multiple Sclerosis, Can Do MS, Consortium of Multiple Sclerosis Centers, International Organization of Multiple Sclerosis Nurses, MS Views and News, Multiple Sclerosis Association of America, Multiple Sclerosis Foundation, National Multiple Sclerosis Society and United Spinal Association

As part of our commitment to ensuring healthy lives and promote well-being, we are providing you a list of resources related to coronavirus (COVID-19).

• A live-tracker of the spread of the disease from Johns Hopkins University.
• The latest updates from the WHO on the virus.
• WHO’s recommendations for the public to reduce exposure.
• The Center for Disease Control’s (CDC) recommendations for traveling.
WHO's rolling updates on coronavirus disease (COVID-19).

We are currently preparing systems and processes to be put in place to manage this issue during the meeting. More detailed information will be posted on our website as soon as we have them confirmed.

We will continue to monitor the situation and will update you on any changes regarding the 2020 CMSC Annual Meeting.


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COVID-19: What You Need to Know

What is COVID-19?

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 illness is a new coronavirus (a type of virus that causes respiratory infections) that was first identified in Wuhan, China in December 2019. Since then, there has been worldwide spread of COVID -19 to nearly every continent. Initially spread appeared to be from those who had traveled from Wuhan, China to other parts of the world. However, at this time it is known that COVID-19 is affecting individuals who have not traveled or have had any contact with travelers. This is considered “community spread.”

What are the symptoms of COVID-19?

Most people who contract COVID-19 will have mild symptoms. Symptoms can include fever, cough, increased fatigue and difficulty breathing (shortness of breath).

How does COVID-19 spread?

COVID-19 can be spread from person to person; particularly if there is close contact (within 6 feet) with someone who is infected. This spread occurs from respiratory droplets produced when the infected person coughs or sneezes directly on another person. COVID-19 can also spread when droplets (from coughs, sneezes or contaminated hands, land on surfaces and another person touches the contaminated surface with their hands and then touches their nose, mouth or possibly eyes with their hands. Spread is more likely when groups of people congregate together. We are following the recommendations from President Trump to avoid gatherings of greater than 10 people.

Are people with MS considered a “higher – risk” group?

The CDC identifies certain conditions as placing people at “higher risk” for infection or complications from COVID-19. This includes people with neurological conditions, such as MS. MS itself does not increase the risk of getting COVID-19, however, certain factors associated with your MS may increase your risk of infection or complications:
    • Taking certain disease modifying therapies
    • Chronic medical conditions, such as lung disease or heart disease
    • Significantly restricted mobility, such as needing to spend most of your day seated or in bed
    • Age 60 or older

Sometimes, the body’s response to infections, including COVID-19, may cause a temporary worsening of MS symptoms. For example, you may have more trouble with fatigue, thinking, mobility, vision or other symptoms. Typically, these symptoms settle down once the infection clears up.

How can I protect myself and others?

There are actions you can take to help prevent the spread of respiratory viruses, including COVID-19.
These include:
    • Wash your hands often with soap and water for at least 20 seconds. Use an alcohol-based hand sanitizer that contains at least 60% alcohol if soap and water are not available.
    • Avoid touching your eyes, nose, and mouth.
    • Cover your cough or sneeze with a flexed elbow or tissue, then throw the tissue in the trash.
    • Clean and disinfect frequently touched objects and surfaces.
    • Practice 'social distancing'. Based upon recommendations from President Trump, social distancing means avoiding gatherings (greater than 10 people) and maintaining distance (approximately 6 feet) from others when possible.
    • Stay home and contact your primary care provider if you develop symptoms of COVID-19, have been in close contact with a person known to have COVID-19, or if you have recently traveled from an area with widespread or ongoing community spread of COVID-19.

Is it ok for my family members or other close contacts to go to work or other types of social gatherings?

Care partners and family members who live with, or regularly visit, a person with MS should also follow the same recommendations to reduce the chance of bringing COVID-19 infection into the home.

What should I do about my MS disease modifying therapies (DMT) because of COVID-19?

There are recommendations about DMTs and COVID-19 coming from multiple individuals, groups and organizations. While each has attempted to provide clarity and sound guidance, differences in the recommendations have created a significant amount of confusion. Decisions regarding disease modifying therapies (DMTs) are made based upon multiple factors, including:
    • Your MS disease course
    • Other medical conditions you may have
    • Allergies to DMTs
    • Other medications that are not compatible with certain DMTs
    • Risks (including infections) vs. benefit of DMT
    • Your values and risk tolerance


The National MS Society, based upon advice from our National Medical Advisory Committee, has developed guidance on the use of DMTs during the COVID-19 pandemic. In addition, we endorse the global advice provided by the MS International Federation (MSIF) – but emphasize that DMT decision making must be individualized and based upon multiple factors, including those listed above.

Both the National MS Society DMT guidance and the MSIF global advice are endorsed by the Consortium of MS Centers and the MS Coalition.

Additional Resources:
CDC Warns Community Spread of Coronavirus is Likely

Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, urged Americans, businesses and hospitals to prepare for potential community spread of the emerging coronavirus, noting "disruption to everyday life might be severe." CDC Principal Deputy Director Anne Schuchat and HHS Secretary Alex Azar said the immediate risk in the US remains low, but rising cases in other countries suggest the US will see an increase beyond the current 57 documented cases.

Full Story: REUTERS (02/25), CNN (02/26)

[Post courtesy of ANA SmartBrief (02/26)]
The MS International Federation (also known as MSIF) has compiled information and a video (see link below) which sufficiently addresses:

1) what the coronavirus is and how to protect against it; and
2) guidance for people living with MS who are taking a disease modifying therapy (DMT) and exposed to or confirmed to have the coronavirus infection

We encourage you to access this information and provide it to individuals affected by MS who may contact the National MS Society (NMSS) with questions about coronavirus and MS.

Any inquiries not addressed by the information/video within the MSIF link can be sent to HealthProf_Info@nmss.org.

CLICK HERE TO VIEW COMPLETE INFORMATION AND ACCESS THE VIDEO
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.

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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.”



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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.”



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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.



    CLICK HERE TO VIEW COMPLETE PRESS RELEASE

    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.


  • CLICK HERE TO VIEW COMPLETE PRESS RELEASE

    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.



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