Press Announcements > FDA approves new oral treatment for multiple s...
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`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm...
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`FDA News Release
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`FDA approves new oral
`treatment for multiple sclerosis
`
`For Immediate Release
`
`March 29, 2019
`
`Release
`
`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
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`Biogen Exhibit 2146
`Mylan v. Biogen
`IPR 2018-01403
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`Press Announcements > FDA approves new oral treatment for multiple s...
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`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm...
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`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 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.
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`Press Announcements > FDA approves new oral treatment for multiple 5...
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`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm...
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`Inquiries
`
`Media
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`8 Sandy Walsh (mailto:sandy.walsh@fda.hhs.gov)
`'~. 301-796-4669
`
`consumers
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`‘. 888—lNFO—FDA
`
`Related Information
`
`0 National Institute of Neurological Disorders and Stroke: Multiple Sclerosis: Hope
`Throu h Research htt s:llwww.ninds.nih. ovIDisordersIPatient-Care iver-
`
`
`Education/Hope-Through-ResearchIMultiple-Sclerosis-Hope-Through-ResearchI
`
`o FDA Approved Drugs: Questions and Answers (IDrugsIResourcesForYou
`IConsumersIucm054420.html
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