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Press Release: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and episodic migraine

Press Release: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and episodic migraine 28.06.2018 – 22:30 | Quelle: Dow Jones Newswire Web | Lesedauer etwa 8 min. | Text vorlesen Stop Pause Fortsetzen facebook google+ twitter *DJ Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and episodic migraine(MORE TO FOLLOW) Dow Jones NewswiresJune 28, 2018 16:30 ET ( 20:30 GMT)Novartis International AG / Novartis presents new data demonstratinglong-term efficacy, safety and tolerability of Aimovig(R) (erenumab) inpatients with chronic and episodic migraine . Processed and transmittedby Nasdaq Corporate Solutions. The issuer is solely responsible for thecontent of this announcement. Results from a one-year study of efficacy and safety of Aimovig inchronic migraine and data from a three-year analysis assessing safety andtolerability of Aimovig in episodic migraine will be presented at AHS Aimovig showed robust efficacy in patients with chronic migraine, withsubstantial reductions in monthly migraine days sustained throughout thestudy Safety data in both studies were consistent with the placebo-like safetyprofile seen for Aimovig across the clinical trial program of 3,000patients Aimovig is the first and only FDA-approved treatment designedspecifically to prevent migraine; EMA approval is expected in the comingmonthsThe digital press release with multimedia content can be accessed here:https://novartis.gcs-web.com/Novartis-presents-new-data-demonstrating-long-term-efficacy-safety-and-tolerability-o-Aimovig-erenumab-in-patients-with-chronic-and-episodic-migraine%20Basel, June 28, 2018 – Novartis today announced the results of twoopen-label extension studies (OLE) of Aimovig(R) (erenumab) in patientswith chronic and episodic migraine, which will be presented at the60(th) Annual Scientific Meeting of the American Headache Society in SanFrancisco[1],[2]. The data reinforce the established safety and efficacyprofile of Aimovig in long-term use for patients with chronic migraine.In addition, data will be presented from the longest running study of aCGRP therapy, demonstrating the long-term safety and tolerability ofAimovig in episodic migraine. Aimovig is the first and only FDA-approvedtreatment specifically developed to prevent migraine by blocking thecalcitonin gene-related peptide receptor (CGRP-R), which is believed toplay a critical role in migraine.In the study in chronic migraine patients (15 or more migraine days permonth), the primary and secondary endpoints were long-term safety andefficacy, respectively[1]. The safety results after one year wereconsistent with the established safety profile of Aimovig in previousstudies. The most frequent adverse events (AEs) were viral upperrespiratory tract infection, upper respiratory tract infection,sinusitis, arthralgia, and migraine.The efficacy data showed sustained benefits up to one year. Compared toa baseline of 18.1 average monthly migraine days, patients takingAimovig 140mg and 70mg (based on last dose received) respectivelyachieved a: Substantial reduction of average monthly migraine days – 10.5 and 8.5days 50% or more reduction in monthly migraine days – 67% and 53% 75% or more reduction in monthly migraine days – 42% and 27% Migraine-free status (100% reduction) – 13% and 6%”These data showing sustained efficacy and consistent safety andtolerability of Aimovig over an extended period of time are importantfor migraine patients and their clinicians to know,” said Stewart J.Tepper, M.D., professor of neurology at the Geisel School of Medicine atDartmouth Medical School. “Collectively these data reinforce the safetyand tolerability of Aimovig, and having a treatment specificallydesigned for migraine has the potential to truly improve the lives ofthose living with this neurological disease.”The results from a three-year interim data analysis of the five-year OLEstudy assessing safety in episodic migraine (four or more migraine daysper month) showed Aimovig had a safety profile consistent with thespectrum and rate of AEs seen in shorter-term placebo-controlledstudies. The most frequent AEs were viral upper respiratory tractinfection, upper respiratory tract infection, sinusitis, influenza, andback pain and there were no new safety signals.”Following FDA approval, with European approval anticipated in thecoming months, we are very pleased to report positive long-term safetyand efficacy results for Aimovig,” said Danny Bar-Zohar, Global Head ofNeuroscience Development at Novartis Pharmaceuticals. “For patients whohave suffered from migraine for years, these new data further confirmthat Aimovig may offer long-term sustained and safe relief from migraineand the heavy burden it imposes.”Aimovig was approved by the FDA on May 17, 2018. The Committee forMedicinal Products for Human Use (CHMP) of the European Medicines Agency(EMA) delivered a positive opinion for Aimovig for the prevention ofmigraine in adults on May 31, 2018. The European Commission will reviewthe CHMP opinion before delivering its final decision.Novartis and Amgen are co-commercializing Aimovig in the U.S, Amgen hasexclusive commercialization rights to the drug in Japan and Novartis hasexclusive rights to commercialize in the rest of the world.About the Open-Label Extension Study in Chronic MigraineAfter the 12-week, Phase II, double-blind placebo-controlled parentstudy, eligible patients could enroll in the OLE. 451 people completedthe study receiving either Aimovig 70 mg, 140 mg or changing from 70 mgto 140 mg during the course of the study. Of the 609 patients whoenrolled in the study, 199 increased their dose from 70 mg to 140 mg byweek 28[1].The primary outcome measure of the study was long-term safety. Thesecondary outcome measure was efficacy, as determined by four measures:change from baseline to week 52 in monthly migraine days (MMD), monthlyacute migraine-specific medication days, monthly cumulative hours ofheadache, and proportion of patients achieving at least a 50% reductionin MMD.The most frequent adverse events (greater than 2.0 per100-subject-years) were viral upper respiratory tract infection, upperrespiratory tract infection, sinusitis, arthralgia, and migraine. In thedouble-blind treatment phase, no differences were observed in the safetyevents between Aimovig and placebo.About the Open-Label Extension Study in Episodic MigraineFollowing a Phase II 12-week double-blind, placebo-controlled study ofAimovig in adults with episodic migraine, patients could enroll in theOLE, initially receiving 70 mg Aimovig monthly. A protocol amendmentincreased the dosage to 140 mg monthly to assess long-term safety of thehigher dose. Safety and tolerability were assessed by monitoring AEs,electrocardiograms, laboratory assessments, and vital signs. Of the 383patients who enrolled in the open-label extension, 235 patients (61.3percent) remained in the OLE study at the data cutoff point for thisinterim analysis, all having received Aimovig for at least three years.The study is continuing for up to five years of treatment.Data at approximately four and five years of treatment will be reportedin the future.Aimovig is the only FDA-approved treatment specifically developed toprevent migraine by blocking the calcitonin gene related peptidereceptor (CGRP-R), which plays an important role in migraine. Aimovighas been studied in several large, global, randomized, double-blind,placebo-controlled studies to assess its safety and efficacy in migraineprevention. More than 3,000 patients have participated in our overall/clinical trial program across the four placebo-controlled Phase II andPhase III clinical studies, their open-label extensions and furtherstudies such as LIBERTY, a dedicated study in a difficult-to-treattreatment failure population.Migraine is a distinct neurological disease[3]. It involves recurrentattacks of moderate to severe head pain that is typically pulsating,often unilateral and associated with nausea, vomiting and sensitivity tolight, sound and odors[4]. Migraine is associated with personal pain,disability and reduced quality of life, and financial cost tosociety[5]. It has a profound and limiting impact on an individual’sabilities to carry out everyday tasks and was reported by the WorldHealth Organization to be one of the top 10 causes of years lived withdisability for men and women[6]. It remains under-recognized andunder-treated[5],[7]. Existing preventive therapies have been repurposedfrom other indications and are often associated with poor tolerabilityand lack of efficacy, with high discontinuation rates among patients[8].About Novartis and Amgen Neuroscience CollaborationIn August 2015, Novartis entered into a global collaboration with Amgento develop and commercialize pioneering treatments in the field ofmigraine and Alzheimer’s disease. The collaboration focuses oninvestigational Amgen drugs in the migraine field, including Aimovig(approved by the FDA in May 2018 for the preventive treatment ofmigraine in adults) and AMG 301 (currently in Phase II development). InApril 2017, the collaboration was expanded to includeco-commercialization of Aimovig in the U.S. For the migraine program,Amgen retains exclusive commercialization rights in Japan, and Novartishas exclusive commercialization rights in Europe, Canada and rest ofworld. Also, the companies are collaborating in the development andcommercialization of a beta-secretase 1 (BACE) inhibitor program inAlzheimer’s disease. The oral therapy CNP520 (currently in Phase III forAlzheimer’s disease) is the lead molecule and further compounds fromboth companies’ pre-clinical BACE inhibitor programs may be consideredas follow-on molecules.Novartis has a strong ongoing commitment to neuroscience and to bringinginnovative treatments to patients suffering from neurological conditionswhere there is a high unmet need. We are committed to supporting(MORE TO FOLLOW) Dow Jones NewswiresJune 28, 2018 16:30 ET ( 20:30 GMT)

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