"First FDAapproved ALS treatment option in more than  years   RADICAVA has been demonstrated to slow decline of physical function by  percent   Comprehensive clinical development program in ALS conducted over a year period  JERSEY CITY N.J. MAY    MT Pharma America Inc. today announced the U.S. Food and Drug Administration FDA has granted approval of RADICAVA edaravone as an intravenous infusion treatment for amyotrophic lateral sclerosis ALS a rapidly progressive neurodegenerative disease in which the majority of patients die within two to five years of diagnosis. People given RADICAVA showed significantly less decline in physical function compared to placebo as measured by the ALS Functional Rating ScaleRevised ALSFRSR a validated rating instrument for monitoring the progression of disability in patients with ALS.  We believe RADICAVA offers new hope for people with ALS and exemplifies MT Pharma Americas commitment to innovative therapies for patients in the United States battling lifethreatening diseases said Atsushi Fujimoto President MT Pharma America. We recognize how important this therapy may be to people with ALS and are committed to helping provide access to this important treatment option with the goal of keeping outofpocket costs at a minimum for eligible patients.  An estimated  Americans are diagnosed each year with ALS an incurable disease that affects the nerve cells in the brain and spinal cord. Initial symptoms can be subtle at first and it can take  to  months to be accurately diagnosed with ALS.  For people with ALS and their families having a new therapy which slows the decline of physical ability is incredibly significant said Jonathan S. Katz M.D. ALS Clinic Director Forbes Norris MDAALS Research and Treatment Center at California Pacific Medical Center. The approval of RADICAVA brings us into a new era of treatment by evolving how we manage this complex disease. This is an uplifting milestone for the ALS community especially since its been so long since we had anything new. The comprehensive clinical development program for RADICAVA in ALS spanned  years and included multiple Phase  trials. The pivotal Phase  study MCI which evaluated  people with ALS formed the basis for the FDA approval of RADICAVA. Data demonstrated patients who received RADICAVA for six months experienced significantly less decline in physical function  by  percent or . ALSFRSR points p..  The most common adverse reactions that occurred in greater than  percent of patients and greater than placebo were bruising contusion problems walking gait disturbance and headache.  MT Pharma America is helping to make RADICAVA accessible to all patients who need it and has created Searchlight Support a patient access program for people with ALS who are prescribed RADICAVA. As soon as a person receives a prescription he or she can access Searchlight Support including personal case management reimbursement support and  clinical support. Some people with ALS who have received prescriptions for RADICAVA may be eligible to receive additional assistance from MT Pharma America. For more information on Searchlight Support contact SRCHLGT . This is an important time for people living with ALS. The approval of RADICAVA gives great promise for what we hope will be the first of many new treatments said Barbara Newhouse President and CEO ALS Association. We applaud the work MT Pharma America and the FDA are doing as they have taken unprecedented steps to get this treatment into the hands of patients as quickly as possible. About the MCI Study  Study MCI was a pivotal Phase  study that evaluated the efficacy and safety of RADICAVA compared with placebo in  people with ALS. In the study after a week preobservation period eligible patients were randomized  to receive RADICAVA  mg intravenously for  minutes or placebo during a sixmonth doubleblind placebocontrolled phase. The primary endpoint for the study was change in the ALS Functional Rating ScaleRevised ALSFRSR score from baseline to six months.  About RADICAVA edaravone  RADICAVA is administered in day cycles by intravenous infusion. It takes  minutes to receive each  mg dose. For the initial cycle the treatment is infused daily for  consecutive days followed by a twoweek drugfree period. All cycles thereafter are infused daily for  days within a day period followed by a twoweek drugfree period.  Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation MTPC and will be commercialized in the U.S. by MT Pharma America. MTPC group companies began researching ALS in  through a comprehensive clinical platform over a year period. In  edaravone was approved for use as a treatment for ALS in Japan and South Korea.  IMPORTANT SAFETY INFORMATION  Before you receive RADICAVA tell your healthcare provider about all of your medical conditions including if you  have asthma.  are allergic to other medicines.  are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.  are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed. Tell your healthcare provider about all the medicines you take including prescription and overthecounter medicines vitamins and herbal supplements. What are the possible side effects of RADICAVA  RADICAVA may cause serious side effects including hypersensitivity allergic reactions and sulfite allergic reactions.    Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.   RADICAVA contains sodium bisulfite a sulfite that may cause a type of allergic reaction that can be serious and lifethreatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.  Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms hives swelling of the lips tongue or face fainting breathing problems wheezing trouble swallowing dizziness itching or an asthma attack in people with asthma.  Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects. The most common side effects of RADICAVA include bruising contusion problems walking gait disturbance and headache. These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to MT Pharma America Inc. at  or FDA at FDA or  http For more information including full Prescribing Information and Patient Information please visit ww.RADICAVA.com http About MT Pharma America  Based in Jersey City N.J. MT Pharma America is a whollyowned subsidiary of Mitsubishi Tanabe Pharma Corporations MTPC  percent owned U.S. holding company Mitsubishi Tanabe Pharma Holdings America Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in the U.S. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners. For more information please visit  http or follow us on Twitter at httpstwitter.comMTPharmaUS. Overview of Mitsubishi Tanabe Pharma Corporation  Mitsubishi Tanabe Pharma which was founded in  has its headquarters in Doshomachi Osaka which is the birthplace of Japans pharmaceutical industry. With business centered on ethical pharmaceuticals Mitsubishi Tanabe Pharma is a wellestablished company and has the longest history of any listed company in Japan In accordance with the corporate philosophy of contributing to the healthier lives of people around the world through the creation of pharmaceuticals the Company formulated the key concept of Open Up the Future under the MediumTerm Management Plan . Through the discovery of drugs that address unmet medical needs centered on its priority disease areas  autoimmune diseases diabetes and kidney diseases central nervous system diseases and vaccines  Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and the license holder of RADICAVA. For more information go to http    National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis ALS Fact Sheet. https Accessed April  .  RADICAVA U.S. Prescribing Information. May   National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis ALS Information Page. https Accessed April  .  Mehta P Kaye W Bryan L et al. . Prevalence of Amyotrophic Lateral Sclerosis  United States . MMWR Surveill Summ No. SS  Simon N. G. Turner M. R. Vucic S. AlChalabi A. Shefner J. LomenHoerth C.  Kiernan M. C. . Quantifying Disease Progression in Amyotrophic Lateral Sclerosis. Annals of Neurology  .  Marin B Boumediene F Logroscino G et al. . Variation in worldwide incidence of amyotrophic lateral sclerosis a metaanalysis. Int J Epidemiol .  ALS Association. Quick Facts about ALS. http Accessed April  .  ALS Therapy Development Institute. What is ALS. http Accessed April  .  Brooks BR. . Risk factors in the early diagnosis of ALS North American epidemiological studies. Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders sup SS.  Research by TOKYO SHOKO RESEARCH LTD."