Press Announcements > FDA approves Zinbryta to treat multiple sclerosis
`
`https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm50...
`
`FDA News Release
`
`FDA approves Zinbryta to treat
`multiple sclerosis
`
`For Immediate Release
`
`May 27, 2016
`
`Release
`
`The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the
`treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-
`acting injection that is self- administered by the patient monthly.
`
`“Zinbryta provides an additional choice to patients who may require a new option for
`treatment,” said Billy Dunn, M.D., director of the Division of Neurology Products in the
`FDA’s Center for Drug Evaluation and Research.
`
`MS is a chronic, inflammatory, autoimmune disease of the central nervous system
`that disrupts communication between the brain and other parts of the body. It is
`among the most common causes of neurological disability in young adults and occurs
`more frequently in women than men. For most people with MS, episodes of
`worsening function (relapses) are initially followed by recovery periods (remissions).
`Over time, recovery may be incomplete, leading to progressive decline in function and
`increased disability. Most people experience their first symptoms of MS between the
`ages of 20 and 40.
`
`The effectiveness of Zinbryta was shown in two clinical trials. One trial compared
`Zinbryta and Avonex in 1,841 participants who were studied for 144 weeks. Patients
`on Zinbryta had fewer clinical relapses than patients taking Avonex. The second trial
`compared Zinbryta with placebo and included 412 participants who were treated for
`52 weeks. In that study, those receiving Zinbryta had fewer relapses compared to
`those receiving placebo.
`
`Zinbryta should generally be used only in patients who have had an inadequate
`response to two or more MS drugs because Zinbryta has serious safety risks,
`including liver injury and immune conditions. Because of the risks, Zinbryta has a
`boxed warning and is available only through a restricted distribution program under a
`Risk Evaluation and Mitigation Strategy.
`
`1 of 3
`
`4/17/2019, 10:40 AM
`
`Biogen Exhibits 2149
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 3
`
`

`

`Press Announcements > FDA approves Zinbryta to treat multiple sclerosis
`
`https://www.fda.gov/newsevents/newsroom/pressannouncements/ucmSO...
`
`The boxed warning tells prescribers that the drug can cause severe liver injury,
`
`including life-threatening and fatal events. Health care professionals should perform
`
`blood tests to monitor the patient’s liver function prior to starting Zinbryta, monthly
`
`before each dose, and for up to six months after the last dose.
`
`The boxed warning also highlights other important risks of Zinbryta treatment
`
`including immune conditions, such as inflammation of the colon (non-infectious
`
`colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy).
`
`Additional highlighted warnings include hypersensitivity reactions (anaphylaxis or
`
`angioedema), increased risk of infections, and symptoms of depression and/or
`suicidal ideation.
`
`The most common adverse reactions reported by patients receiving Zinbryta in the
`
`clinical trial that compared it to Avonex include cold symptoms (nasopharyngitis),
`
`upper respiratory tract infection, rash, influenza, dermatitis, throat (oropharyngeal)
`
`pain, eczema, and enlargement of lymph nodes. The most common adverse
`
`reactions reported by patients receiving Zinbryta when compared to placebo are
`
`depression, rash, and increased alanine aminotransferase.
`
`Zinbryta is manufactured by Biogen, Inc. of Cambridge, Massachusetts.
`
`The FDA, an agency within the US. 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.
`
`###
`
`Inquiries
`
`Media
`
`8 Sang Walsh (mailto:sandy.walsh@fda.hhs.gov)
`L 301-796-4669
`
`Consumers
`
`k 888—lNFO—FDA
`
`Follow FDA
`
`Follow @US FDA (httpszlltwittemomlus FOAM?(IAboutFDAIAboutThisWebsite
`IWebsitePoliciesIDisclaimersldefaultmtml
`
`Page 2 of 3
`
`20f3
`
`4/17/2019. 10:40 AM
`
`

`

`Press Announcements > FDA approves Zinbryta to treat multiple sclerosis
`
`https://www.fda.gov/newsevents/newsroom/pressannouncements/ucmSO...
`
`Follow FDA 1hgpsfllwwwjaceboohcomIFDA)[£1(IAboutFDAIAboutThisWebsite
`IWebsitePoliciesIDisclaimersldefaultmtm)
`
`Follow @FDAmedia (ht_tps:lltwitter.comIFDAMedia) |§ (IAboutFDA
`IAboutThisWebsiteMIebsitePoliciesIDisclaimersIdefault.htm
`
`More in Press Announcements
`
`[INewsEventsINewsroomIP ressAnnouncementsIdefault.htm|
`
`2017 (INewsEvents/NewsroomIPressAnnouncementslzo17Idefault.htm)
`
`2016 [INewsEvents/NewsroomlPressAnnouncemems/2016/default.htm)
`
`Page 3 of 3
`
`3 of3
`
`4/17/2019. 10:40AM
`
`