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`FDA approves new oral treatment for multiple sclerosis | FDA
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`FDA NEWS RELEASE
`FDA approves new oral treatment for multiple sclerosis
`
`For Immediate Release:
`March 29, 2019
`
`The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of
`multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease.
`Mavenclad is not recommended for MS patients with clinically isolated syndrome. Because of its safety profile, the use of
`Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an
`alternate drug indicated for the treatment of MS.
`
`“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis,”
`said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and
`Research. “The approval of Mavenclad represents an additional option for patients who have tried another treatment
`without success.”
`
`MS (https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-
`Hope-Through-Research) is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts
`communications between the brain and other parts of the body. Most people experience their first symptoms of MS
`between the ages of 20 and 40. MS is among the most common causes of neurological disability in young adults and occurs
`more frequently in women than in men.
`
`For most people, MS starts with a relapsing-remitting course, in which episodes of worsening function (relapses) are
`followed by recovery periods (remissions). These remissions may not be complete and may leave patients with some
`degree of residual disability. Many, but not all, patients with MS experience some degree of persistent disability that
`gradually worsens over time. In some patients, disability may progress independent of relapses, a process termed
`secondary progressive multiple sclerosis (SPMS). In the first few years of this process, many patients continue to
`experience relapses, a phase of the disease described as active SPMS. Active SPMS is one of the relapsing forms of MS, and
`drugs approved for the treatment of relapsing forms of MS can be used to treat active SPMS.
`
`The efficacy of Mavenclad was shown in a clinical trial in 1,326 patients with relapsing forms of MS who had least one
`relapse in the previous 12 months. Mavenclad significantly decreased the number of relapses experienced by these patients
`compared to placebo. Mavenclad also reduced the progression of disability compared to placebo.
`
`Mavenclad must be dispensed with a patient Medication Guide that describes important information about the drug’s uses
`and risks. Mavenclad has a Boxed Warning for an increased risk of malignancy and fetal harm. Mavenclad is not to be used
`in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, health care
`professionals should evaluate the benefits and risks of the use of Mavenclad on an individual patient basis. Health care
`professionals should follow standard cancer screening guidelines in patients treated with Mavenclad. The drug should not
`be used in pregnant women and in women and men of reproductive potential who do not plan to use effective
`contraception during treatment and for six months after the course of therapy because of the potential for fetal harm.
`Mavenclad should be stopped if the patient becomes pregnant.
`
`Other warnings include the risk of decreased lymphocyte (white blood cell) counts; lymphocyte counts should be
`monitored before, during and after treatment. Mavenclad may increase the risk of infections; health care professionals
`should screen patients for infections and treatment with Mavenclad should be delayed if necessary. Mavenclad may cause
`hematologic toxicity and bone marrow suppression so health care professionals should measure a patient’s complete blood
`Merck 2040
`Hopewell v Merck
`IPR2023-00480
`
`https://www.fda.gov/news-events/press-announcements/fda-approves-new-oral-treatment-multiple-sclerosis
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`FDA approves new oral treatment for multiple sclerosis | FDA
`11/25/23, 11:59 AM
`counts before, during and after therapy. The drug has been associated with graft-versus-host-disease following blood
`transfusions with non-irradiated blood. Mavenclad may cause liver injury and treatment should be interrupted or
`discontinued, as appropriate, if clinically significant liver injury is suspected.
`
`The most common adverse reactions reported by patients receiving Mavenclad in the clinical trials include upper
`respiratory tract infections, headache and decreased lymphocyte counts.
`
`The FDA granted approval of Mavenclad to EMD Serono, Inc.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the
`safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use,
`and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics,
`dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
`
`
`Related Information
`National Institute of Neurological Disorders and Stroke: Multiple Sclerosis, Hope through Research
`(https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-
`Hope-Through-Research)
`
`FDA approved drugs: Questions and Answers (/drugs/information-consumers-and-patients-drugs/approved-drugs-
`questions-and-answers)
`
`###
`
`Inquiries
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`
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