May 20, 2020 News by Marisa Wexler, MS Glatopa Shows Efficacy Similar to Copaxone, Study in Real-world Use Finds Glatopa, a generic form ofĀ Copaxone, is as effective as the brand-name medication in terms of disease outcomes and has similar healthcare-related costs in real-world use in patients with relapsingĀ multiple sclerosis (MS), a new U.S. study suggests. Data also suggest a trend toward lower relapse rates with Glatopa…
May 12, 2020 News by Marta Figueiredo, PhD COVID-19 May Not Be Severe in MS Patients, Early Data from Italy Suggest People with multiple sclerosis (MS) may not be at higher risk of developing a severe COVID-19 infection, according to preliminary data from patients in Italy. āAt the moment, these results seem to be quite reassuring for most people with MS,ā Marco Salvetti, MD, PhD, professor at Sapienza…
April 1, 2020 News by Marisa Wexler, MS Biosimilar Truxima Works as Well as Rituximab Originator in MS, Study Finds Truxima, aĀ biosimilar of rituximab, is comparable to the originator therapy in terms of effectiveness and safety for treatingĀ multiple sclerosis (MS), a new study suggests. Rituximab āĀ marketed asĀ RituxanĀ in the United States ā isĀ an antibody-based therapy thatĀ works by killing B-cells, which are immune cells…
October 9, 2019 News by Grace Frank US Supreme Court Denies Acorda Appeal on Ampyra Patents, Supporting Generic Versions The U.S. Supreme Court gave a green light to generic versions of Ampyra this week, declining to hearĀ Acorda Therapeutics‘ appeal of a lower court ruling that allowed generics of its treatment for walking or gait problems in multiple sclerosis. That lower court rulingĀ came fromĀ the U.S. District Court…
May 16, 2019 News by Jose Marques Lopes, PhD #AANAM – Gilenya at 0.5 mg Superior to Copaxone at Lowering Relapses, Phase 3 Trial Shows Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior toĀ Copaxone (glatiramer acetate) injections at lowering relapses and disease activity over one year in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a Phase 3b trial. The research, āEfficacy and Safety…
September 7, 2018 News by Diogo Pinto Active Biotech Regains Full Rights to Laquinimod from Teva, Plans to Continue Work on Potential MS Oral Therapy Active Biotech announced it has regained global development and commercialization rights over laquinimod, its investigational oral therapy for multiple sclerosis (MS), from Teva Pharmaceuticals. Teva released rights to laquinimod after the company decided not to continue with its clinical development. Teva will give Active Biotech full…
June 28, 2018 News by Vijaya Iyer, PhD Laquinimod, Potential PPMS Therapy, Seen to Ease Damage to Vision in Mouse Model Treating mice in a model of multiple sclerosis (MS)Ā with laquinimod before the onset of symptoms eased inflammation so as to help preserve their vision ā lessening damage to the optic nerve and retina, a study from Germany reports. The study, āLaquinimod protects the optic nerve and…
May 16, 2018 News by Patricia Silva, PhD 4 Relapsing MS Treatments Added to UK Health Service After Cuts to Prices Agreed After an agreement to lower their prices, four treatments for relapsing multiple sclerosis āĀ Biogenās AvonexĀ and Merck KGaA‘sĀ Rebif (both interferon beta-1a), Novartisā ExtaviaĀ (interferon beta 1b), and Tevaās Copaxone (glatiramer acetate) ā were recommended as cost-effective and long-term therapy options within the National Health Service…
May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
April 11, 2018 News by Alice MelĆ£o, MSc Mapi Pharma, Mylan Partner to Develop Once-monthly Glatiramer Formulation Mylan andĀ Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapyĀ CopaxoneĀ (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…
February 27, 2018 Columns by Ed Tobias What’s Hot and What’s Not Among MS Therapies? The newest kids on the MS block, disease-modifying therapies (DMT) such as Genentech’s Ocrevus (ocrelizumab) and Sanofi Genzyme’s Lemtrada (alemtuzumab), are attracting a lot of interest these days. But, some DMTs that have been around for more than two decades are still being prescribed by a lot of neurologists.
February 1, 2018 News by Jose Marques Lopes, PhD Mapi Pharma Doses First PPMS Patient in Phase 2 Trial Evaluating GA Depot The Phase 2a trial of GA Depot (glatiramer acetate) for the treatment of primary progressive multiple sclerosis (PPMS) has dosed the first patient,Ā Mapi PharmaĀ recently announced. In the U.S., Copaxone (glatiramer acetate injection, marketed by Teva Pharmaceutical) is the standard therapy for relapsing-remitting multiple sclerosis (RRMS), which is…
January 26, 2018 News by Jose Marques Lopes, PhD Brabio, 1st Generic Version of Copaxone for Relapsing MS, Launched in UK Brabio (glatiramer acetate injection), the first generic alternative to CopaxoneĀ for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker,Ā Mylan, announced. Similar to Copaxone Ā ā developed by TevaĀ āĀ Brabio is now available at a 40 mg/ml dose. Both medications are…
December 5, 2017 News by Marta Figueiredo, PhD Laquinimod Fails to Slow Brain Atrophy and PPMS Progression, Says Developer Active Biotech Sweden'sĀ Active BiotechĀ said its experimental therapyĀ LaquinimodĀ failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potentialĀ to treat primary progressive multiple sclerosis. Laquinimod, also known asĀ NerventraĀ orĀ ABR-215062, was developed by Active Biotech and Israel'sĀ Teva Pharmaceutical Industries. The drug targets inflammation and degeneration in neurological tissue. Preclinical studies using animal models of multiple sclerosis showed that laquinimod regulated inflammatory and immune responses in these animals, reducing disease progression. The ARPEGGIO Phase 2 study aimed to evaluate laquinimod's efficacy, safety and tolerability in PPMS patients. Its primary endpoint was brain atrophy as defined by percent brain volume change. Secondary goals included time to disability progression, change in timed 25-foot walk, and number of new T2 lesions. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 374 individuals. Initially, the study aimed to evaluate two doses of laquinimod ā 0.6 and 1.5 mg/day ā in PPMS compared to placebo. However, the highest dose was discontinued in January 2016 after some participants reported adverse cardiovascular events. In a Dec. 1 press release,Ā Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression.Ā āThere was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,ā said the company's president and CEO, HelĆ©n Tuvesson. The trial revealed a similar safety profile to that observed in previous studies in relapsing-remitting MS patients (RRMS). The most common adverse reactions were headache, nasopharyngities, upper respiratory tract infection,and back pain. Results of the ARPEGGIO trial will likely be presented at a future scientific conference and published in a scientific journal. Earlier this year, Active BiotecĀ stopped developing laquinimod as a potential RRMS treatment after a Phase 3 study failed to achieve its primary goal: slowing disease progression. Laquinimod is also being evaluated as a potential therapy for Huntingtonās disease in a Phase 2 clinical trial.
November 9, 2017 News by Marta Figueiredo, PhD Survey Helps Improve Communication Between Women with MS and Healthcare Providers A national survey in the U.S. revealed that 98% of women newly diagnosed with multiple sclerosis struggle to discuss important personal concerns with their healthcare team.
October 5, 2017 News by Patricia Silva, PhD FDA Approves Mylanās Generic Copaxone, Introducing First Generic High-Dose Version The U.S. Food and Drug Administration has approved both lower and higher doses ofĀ Mylanās generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL ā intended for…
September 18, 2017 News by Patricia Silva, PhD Synthon Wins EU Patent Case Against Teva, Paving Way for Generic Copaxone for MS Patients AĀ European Patent OfficeĀ decision has opened the door toĀ SynthonĀ providing cheaper generic versions of Teva Pharmaceuticalās Copaxone to people withĀ relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’sĀ Technical Board of Appeal revoked the last of the patents that Teva…
September 14, 2017 Columns by Laura Kolaczkowski Thereās an App (Maybe Too Many) for That! How many hours do the pharmaceutical companies think we have in our day? I ask because almost all of them have come up with very slick tools to use, particularly mobile apps, to help us improve our daily lives with MS. Not coincidentally, these apps also provide their…
July 17, 2017 News by Alice MelĆ£o, MSc Copaxone Benefits RRMS Patients in the Long Term by Modulating Immune System Responses, Study Shows First-line treatment with Copaxone (glatiramer acetate)Ā benefits relapsing-remitting multiple sclerosis (RRMS) patientsĀ by boosting the number of anti-inflammatory immune cells and restoring the balance of regulatory immune cells, an Italian study shows. TheĀ study, āBiological activity of glatiramer acetate on Treg and anti-inflammatory monocytes persists for more than 10…
May 25, 2017 News by Patricia Silva, PhD Teva Pharmaceuticals Europe Launches ‘Life Moments with MS’ to Mark May 31, World MS Day May 31 isĀ World MS Day. In its honor, Teva Pharmaceuticals Europe has launched āLife Moments with MS” ā a social media campaign to raise awareness about theĀ challenges people with multiple sclerosis (MS) face every day. Tevaās campaign, which uses the hashtag #LifeMomentswithMS, also includes educational resources on what…
May 9, 2017 News by Alice MelĆ£o, MSc Laquinimod Fails to Meet Primary Clinical Trial Goal of Slowing Progression of RRMS LaquinimodĀ failed to meet its primary Phase 3 clinical trial objective of slowing the progression ofĀ relapsing-remitting multiple sclerosis (RRMS) after three months, according to its developers,Ā Teva Pharmaceutical Industries and Active Biotech. That has prompted the partners to abandon their quest to use the therapy to treat RRMS. Laquinimod…
May 8, 2017 News by Joana Fernandes, PhD Pregnant Women with Relapsing MS Can Use Copaxone Without Harming Baby, Study Indicates Babies of women with relapsing multiple sclerosis (RMS) who receive daily injections ofĀ Copaxone (glatiramer acetate) while pregnant carry the same risk of developing birth defects as babies as a whole, according to a study by the therapy’s developer,Ā Teva Pharmaceutical Industries. The findings can help doctors counsel and treat…
January 7, 2016 News by Patricia Silva, PhD MS Drug Under Study No Longer Being Given in Higher Doses to Patients Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation byĀ the Data Monitoring Committee (DMC)Ā that isĀ supervising the clinical trials afterĀ cardiovascular events, none of which were fatal,…
December 7, 2015 News by Patricia Silva, PhD Relapsing Multiple Sclerosis Treatment Now Available in Japan Takeda Pharmaceutical, a pharmaceutical company based in Osaka, Japan, recently announcedĀ that a widely approved drug treatment forĀ the prevention of relapses in multiple sclerosis (MS)Ā is nowĀ available in Japan as well. Copaxone,Ā (glatiramer acetate; 20 mg daily subcutaneous injection), developed by Teva Pharmaceuticals, is an immunomodulatory drug designed toĀ act as…
October 9, 2015 News by Patricia Silva, PhD Discovering a New World in MS Through Genomics, ECTRIMS 2015 A Satellite Symposia entitled āDiscovering a new world in MSā supported by Teva Neuroscience was held yesterday, October 8, at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), currently taking place in Barcelona, Spain, October 7 ā 10, 2015. Prof. David Brassat…
August 3, 2015 News by Patricia Silva, PhD MS Views and News Announces August Educational Events The non-profit organization MSĀ News and ViewsĀ (MSVN) announced that it will host four educational events during the month of August for both patients and other peopleĀ interested in learning more aboutĀ multiple sclerosis (MS). The educational events reflectĀ the organization’s ongoing mission, which is to collect, present and…
January 9, 2015 News by Charles Moore Takeda Submits Application For New Multiple Sclerosis Relapse Prevention Drug Glatiramer Acetate in Japan Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetateĀ (active ingredient)Ā — which is sold in some marketsĀ under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…