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FDA Approves Cladribine -- Brand named Mavenclad® -- for People with Relapsing-Remitting MS and Active Secondary Progressive MS - UPDATE

March 29, 2019

UPDATED 4/2/19 with additional details and FAQs

SUMMARY
  • The U.S. Food and Drug Administration has approved oral cladribine (brand named Mavenclad®- EMD Serono) for the treatment of adults with relapsing forms of MS, including relapsing-remitting MS and active secondary progressive MS, based on clinical trials showing it could decrease the number of relapses and slow the accumulation of physical disability caused by MS, compared to placebo. Because of its safety profile, Mavenclad is generally recommended in people with MS who have had an inadequate response to, or are unable to tolerate, another MS therapy.
  • Mavenclad is a compound that targets certain types of white blood cells (lymphocytes) that drive the immune attack in MS. It temporarily reduces the number of both T and B lymphocytes without continuous suppression of the immune system.
  • Mavenclad has a boxed warning due to an increased risk of cancers and risk of fetal (unborn baby) harm.
  • Potential safety issues identified by the FDA include decrease in white blood cells, and increased risk of infections and liver injury. The most common adverse reactions reported during clinical trials included upper respiratory tract infections, headache, and low white blood counts.
  • Mavenclad is taken by mouth in two treatment courses, twelve months apart. 
“This is an important breakthrough for people who do not respond to alternatives that have been approved to treat relapsing-remitting or active secondary progressive MS,” said Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society. “We are grateful that there is an additional option for people affected by these forms of MS.”
 
Read the FDA’s press release
Download the Medication Guide for consumers
Download the prescription information for professionals
 
DETAILS
The U.S. Food and Drug Administration has approved oral cladribine (Mavenclad®- EMD Serono) for use in the treatment of adults with relapsing forms of MS, including relapsing-remitting MS and active secondary progressive MS. Because of its safety profile, Mavenclad is generally recommended in people with MS who have had an inadequate response to, or are unable to tolerate, another MS therapy.
  • Mavenclad has not been tested in children.
  • Mavenclad is not recommended for use in people with clinically isolated syndrome (CIS) because of its safety profile. 
Mavenclad is not recommended for people who:
  • have cancer.
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and not using birth control
  • are HIV (human immunodeficiency virus) positive.
  • have active infections, including tuberculosis and hepatitis.
  • are breastfeeding.
Types of MS For Which Mavenclad is Approved: Mavenclad is approved for the treatment of adults with relapsing forms of MS including relapsing-remitting MS and active secondary progressive MS. Relapsing-remitting MS – the most common disease course – is characterized by clearly defined attacks of new or increasing neurologic symptoms. These attacks – also called relapses or exacerbations – are followed by periods of partial or complete recovery (remissions). Secondary progressive MS follows an initial relapsing-remitting course.
 
Many people who are initially diagnosed with relapsing-remitting MS eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function over time. Some people with secondary progressive MS can be characterized as either active or not active, as well as with progression or without progression. Those with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
 
About Mavenclad: Mavenclad is a compound that targets certain types of white blood cells that drive the immune attack in MS. It temporarily reduces the number of both T and B cells without continuous suppression of the immune system. Mavenclad is a tablet, taken by mouth in two treatment courses, twelve months apart.
 
Potential Benefits: A phase III clinical trial (CLARITY) tested the safety and effectiveness of oral Mavenclad in 1,326 people with relapsing-remitting MS. Investigators compared the effects of two doses of Mavenclad (3.5 mg/kg, and 5.25 mg/kg) against an inactive placebo and followed participants for up to 2 years. Those taking the lower dose of Mavenclad had a 58% reduction in annual relapse rate compared to people in the placebo group, and those taking the higher dose had a 55% reduction compared to placebo. People taking Mavenclad also had a lower risk of sustained disability progression at 3 months as measured by the EDSS scale and had less disease activity on MRI scans.
 
Potential Risks: Prescribing information for includes several warnings and precautions, including a boxed warning for increased risk of cancers and birth defects/fetal harm. Women and men should use birth control before and at least 6 months after the last dose of Mavenclad. The most common adverse reactions reported during clinical trials included upper respiratory tract infections, headache, and low white blood counts.
 
Please see the prescribing information for the full list of warnings and precautions. Other potential risks include:
  • Low blood cell counts
  • Infections
  • Graft-Versus-Host Disease with blood transfusion (serious condition where cells in the transfused blood react to the body)
  • Liver injury
  • Hypersensitivity (allergic reaction)
  • Heart failure
Pre-dosing Tests and Ongoing Evaluations: The prescribing information contains advice to health care providers about tests people should undergo before beginning to take Mavenclad. These include:
  • Blood tests including a complete blood count, liver function tests and screening for acute or latent infections including HIV, Tuberculosis, hepatitis.
  • Blood counts (lymphocytes) should be monitored before, during and after treatment with Mavenclad. Lymphocytes must be within normal range before initiating the first treatment course, and at least 800 cells per microliter before initiating the second treatment.
  • Blood test for antibodies to varicella zoster virus (Shingles virus). In those who are negative, Shingles vaccination is recommended. Administer other immunizations according to standard guidelines prior to starting Mavenclad. Live vaccines or live-attenuated vaccines should be administered at least 4-6 weeks prior to dosing.
  • For women with reproductive potential, administer pregnancy test.
  • Screen for cancer following standard screening guidelines.
  • Baseline (within 3 months of treatment start) MRI imaging prior to the first treatment course because of the risk of progressive multifocal leukoencephalopathy (PML).
EMD Serono plans to offer patient support through MS LifeLines®, including assistance with navigating insurance questions and additional resources that may assist those who are uninsured or underinsured. www.mslifelines.com/or call 1-877-447-3243
 
Resources:
Read the FDA’s press release
Download the Medication Guide for consumers
Download the prescription information for professionals
 

Frequently Asked Questions About Mavenclad Approval

Q. What types of MS is Mavenclad approved to treat?
A. The FDA has approved oral Mavenclad for the treatment of adults with relapsing forms of MS, including relapsing-remitting MS and active secondary progressive MS.  Because of its safety profile, Mavenclad is generally recommended in adults with MS who have had an inadequate response to, or are unable to tolerate, another MS therapy.
 
Q. How is Mavenclad taken?
A. Mavenclad is a pill, taken by mouth. The dose is determined by body weight and is given in two treatment courses spread over 2 years. Each yearly treatment consists of 2 treatment weeks (4 or 5 days) that will occur about one month apart.
 
Q. Why should a person with MS consider taking a disease-modifying therapy?
A. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Studies comparing people in clinical trials who started therapy earlier than those on inactive placebo suggest that early treatment offered important benefits against the accumulation of disability, which were generally not experienced to the same degree by those who started treatment later.
 
Selecting an MS therapy should be determined by people with MS in collaboration with the healthcare provider who treats their MS, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
 
Q. Should I switch from my current therapy to Mavenclad?
A. The decision about whether to take Mavenclad should be made in collaboration with the healthcare provider who treats your MS, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your provider in terms of Mavenclad include:
  • How am I doing on my current therapy?
  • What is my tolerance for the risk of known side effects?
  • How will my medication choice affect my ability or plans to become pregnant or to father a child?
  • What are the comparative costs of my current therapy versus Mavenclad?
Q. How does the effectiveness of Mavenclad compare to other available therapies?
A. We don’t have sufficient information to answer this question, based on the clinical trial conducted for the approval of Mavenclad. In that trial, Mavenclad was not compared to other MS therapies.

Q. If I have been taking another disease-modifying therapy for MS, how long will I have to wait before starting Mavenclad?
A. If you have taken one or more therapies that suppresses the immune system, (such as methotrexate, cyclosporin, cyclophosphamide and azathioprine), Mavenclad could further reduce your immune system’s ability to fight infection. Before taking Mavenclad, your blood cell counts will guide your healthcare provider’s decision on when or whether to start Mavenclad.
 
Q. What are the potential side effects of Mavenclad?
A. Please see the prescribing information for the full list of warnings and precautions. Prescribing information for includes several warnings and precautions, including a boxed warning for increased risk of cancers and birth defects/fetal harm. Women and men should use birth control before and at least 6 months after the last dose of Mavenclad. The most common adverse reactions reported during clinical trials included upper respiratory tract infections, headache, and low white blood counts. In addition, other potential risks include:
  • Low blood cell counts
  • Infections
  • Graft-Versus-Host Disease with blood transfusion
  • Liver injury
  • Hypersensitivity (allergic reaction)
  • Heart failure
Q. How long would a person take Mavenclad?
A. The total dose of Mavenclad is based on body weight, and this is reached after 2 years of treatment. After the second dose in year two of treatment, individuals are observed for an additional two years. People who took part in the clinical trials did not need further treatment with Mavenclad in years three and four. The safety and efficacy of taking Mavenclad more than 2 years after completing 2 treatment courses has not been studied.
 
Q. Are there any risk factors or medical conditions that would make it inappropriate for an individual to take Mavenclad?
A. Mavenclad may not be appropriate if you have existing medical conditions including liver problems, active cancer, serious infections such as HIV or tuberculosis. Mavenclad should not be taken if you are pregnant or breastfeeding. Mavenclad can cause fetal harm when administered to a pregnant woman. Women of childbearing potential, as well as men, should use effective contraception during therapy and for 6 months after the last dose. A barrier contraceptive method should be used with hormone contraceptives until 4 weeks after the last dose of Mavenclad. Mavenclad may interact with some medications and you should tell your healthcare provider about all of the medications you are taking.
 
Q. Will people taking have to get any special medical tests or monitoring?
A. Yes. Tests and evaluations include:
  • Blood tests including a complete blood count, liver function tests and screening for acute or latent infections including HIV, TB, hepatitis.
  • Blood counts (lymphocytes) should be monitored before, during and after treatment with Mavenclad. Lymphocytes must be within normal range before initiating the first treatment course, and at least 800 cells per microliter before initiating the second treatment.
  • Blood test for antibodies to varicella zoster virus (Shingles virus). In those who are negative, VZV vaccination is recommended. Administer other immunizations according to standard guidelines prior to starting Mavenclad. Live vaccines or live-attenuated vaccines should be administered at least 4-6 weeks prior to dosing.
  • For women with reproductive potential, administer pregnancy test.
  • Screen for cancer following standard screening guidelines.
  • Baseline (within 3 months) MRI imaging prior to the first treatment course because of the risk of progressive multifocal leukoencephalopathy (PML).
Q. What will Mavenclad cost?
A. The wholesale acquisition cost (WAC) of Mavenclad is $99,500 annually. The price to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs. EMD Serono is offering patient support through MS LifeLines®, including assistance with navigating insurance questions and additional resources that may assist those who are uninsured or underinsured. www.mslifelines.com/or call 1-877-447-3243

Q. Where can I get information about the support that EMD Serono will provide to help people gain access to Mavenclad?
A. EMD Serono plans to offer support to healthcare providers and people with MS through MS LifeLines®, including assistance with navigating insurance questions and additional resources that may assist those who are uninsured or underinsured. www.mslifelines.com/ or call 1-877-447-3243.
 
Q. What other disease-modifying therapies are available for MS?
A. Other disease-modifying therapies are available for people living with relapsing forms of MS, primary progressive MS, and clinically isolated syndrome (an initial neurological episode). These include therapies that are taken by mouth, injection, and infusion.
 
Q. Is Mavenclad being tested in progressive MS?
A. Not at this time.
 
Q. Are there other therapies in development for progressive MS?
A. Yes. The National MS Society is closely watching experimental treatments in development for people with progressive forms of MS. In addition, other studies include:
  • Investigators at Oregon Health & Science University are conducting a Phase 2 clinical trial to determine if the oral supplement, lipoic acid, is an effective treatment for progressive forms of MS. The trial is co-funded by the Veteran’s Administration and the National MS Society.
  • The SPRINT-MS trial of Ibudilast, an oral anti-inflammatory agent, demonstrated that it was well tolerated and significantly slowed the rate of brain atrophy compared to placebo in people with secondary progressive and primary progressive MS. This trial was a unique collaboration between NIH's NeuroNEXT Network, MediciNova, and the National MS Society.
  • The MS-STAT2 study is underway at University College London, a multicenter trial testing whether a repurposed cholesterol-lowering therapy can slow the course of secondary progressive MS; the Society is providing funding.
The Society is also very interested in wellness research to identify exercise, dietary and other approaches that will help people who have MS live their best lives. The Society supports several clinical trials that are investigating dietary interventions for symptom management and for their potential to modify the disease process.
 
Q: Based on these trial results, is there still a need to invest in additional research on progressive MS?
A: Yes. We need to continue our investment in research to find solutions for progressive MS. We welcome recent developments, but we must remain focused on finding more and better solutions for treating progressive MS. We will do this by our continued leadership in the International Progressive MS Alliance and by funding research on progressive MS through our own research programs, and by encouraging other companies to commit to developing treatments for progressive forms of MS.
 
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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