July 19, 2022 News by Marisa Wexler, MS Natalizumab, Tysabri Biosimilar, Up for Approval in Europe The European Medicines Agency (EMA) has agreed to review a request to approveĀ Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS). This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, anĀ approved MS treatment. “The acceptance…
September 20, 2021 News by Marisa Wexler, MS Vumerity Recommended for EU Approval as RRMS Treatment A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
February 1, 2021 News by Marisa Wexler, MS CHMP Favors Kesimpta for Adults With Relapsing MS in Europe A branch of the European Medicines Agency (EMA) has recommended thatĀ Kesimpta (ofatumumab) be approved and made available to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. A final decision from the European Commission (EC) is expected in about two months. Typically, the EC follows…
June 1, 2020 News by InĆŖs Martins, PhD Two-hour Ocrevus Infusion Time Approved for MS Patients in Europe The European Medicines Agency (EMA) approved a shorter infusion time for Ocrevus (ocrelizumab), an approved treatment for people with relapsing or primary progressive multiple sclerosis (MS). The approval follows a positive recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP),…
April 21, 2020 News by Marisa Wexler, MS Shorter Ocrevus Infusion Time Up for Approval in US and Europe The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications from Genentech to shorten the infusion time for Ocrevus, an approved treatment forĀ multiple sclerosis. If approved, the time to administer Ocrevus will be shortened to a two-hour session, instead…
March 30, 2020 News by Marta Figueiredo, PhD CHMP Favors Zeposia (Ozanimod) as Oral Treatment for Active RRMS in EU TheĀ Committee for Medicinal Products for Human UseĀ (CHMP) has recommended Zeposia (ozanimod) oral capsules to be approved in the European Union (EU) to treat adults with active relapsing-remitting multiple sclerosis (RRMS). Opinions released by CHMP, an arm of theĀ European Medicines AgencyĀ (EMA), are generally accepted by the European Commission,…
March 5, 2020 News by Marisa Wexler, MS Janssen Asks EMA to Approve Oral Ponesimod to Treat Relapsing MS JanssenĀ has submitted an application toĀ the European Medicines Agency (EMA) asking that ponesimodĀ be approved as an oral treatment for adults with relapsing multiple sclerosis (MS) in the European Union. Ponesimod (formerly ACT-128800) is an experimental treatment that targets theĀ sphingosine-1-phosphate receptor…
February 25, 2020 News by Patricia Inacio, PhD Novartis’ Ofatumumab for Relapsing MS Up for Possible Approval by FDA and EMA Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, anĀ investigational B-cell therapy for the treatment of relapsing forms ofĀ multiple sclerosisĀ (MS) in adults. Novartis’ applications for ofatumumab ā which has the…
November 5, 2019 News by Ana Pena PhD EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk…
September 24, 2019 News by Marisa Wexler, MS Interferon Beta Use by Pregnant and Breastfeeding Patients OK, Office in Europe Says If necessary, women with relapsing multiple sclerosis can continue treatments based on interferon beta while pregnant and breastfeeding, according to an updated recommendation by an office of the European Medicines Agency (EMA). Interferon beta-based treatments are a mainstay of approved MS therapies. Three specific treatments were mentioned in press…
June 10, 2019 Columns by Ed Tobias MS News That Caught My Eye Last Week: Ozanimod for RRMS, MS Monitoring App, Video Series FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…
June 7, 2019 News by Joana Carvalho, PhD FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both agreed to review for possible approvalĀ ozanimod, Celgene‘s investigational oral therapy for relapsing forms of multiple sclerosis (MS). An FDA decision on the company’sĀ New Drug Application for ozanimod is expected on…
April 18, 2019 News by Joana Carvalho, PhD EMA Reviewing Safety Data for Lemtrada After Reports of Serious Treatment Side Effects The European Medicines Agency (EMA) is reviewing safety data for Sanofi Genzyme‘sĀ LemtradaĀ (alemtuzumab) following new reports of serious treatment side effects. Lemtrada is a humanized monoclonal antibody used to slow disease progression in adult patients with relapsing-remitting multiple sclerosis (RRMS). It works by blocking the activity of…
March 12, 2019 News by Jonathan Grinstein Celgene Seeks Approval in European Union for Ozanimod to Treat Adult RRMS An application has been submitted for the use of ozanimod to treat adult patients withĀ relapsing-remitting multiple sclerosis (RRMS)Ā within the European Union, according toĀ Celgene, the developer of ozanimod. The marketing authorization application was submitted to the European Medicines Agency…
October 10, 2018 News by Alice MelĆ£o, MSc FDA, EMA Agree to Review Novartis Therapy Siponimod to Treat SPMS Novartis is seeking U.S. and European approval of its investigational oral agent siponimodĀ to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…
November 14, 2017 News by Alice MelĆ£o, MSc Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS Europeans with relapsing multiple sclerosis (MS) andĀ earlyĀ primary progressive MS are one step closer to accessingĀ Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion ā announced inĀ a press release issued Nov. 10 by the EMAās Committee for Medicinal Products for Human UseĀ ā is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whetherĀ OcrevusĀ should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens,Ā any decisions on price or insurance reimbursements will be the responsibility of each member state. OcrevusĀ wonĀ U.S. approval earlier this year. It was alsoĀ recentlyĀ approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division ofĀ Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Seronoās approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.
August 22, 2017 News by Patricia Silva, PhD Mavenclad Improves Relapsing MS Patientsā Quality of Life, Independent U.K. Study Finds Merckās Mavenclad tablets significantly improve quality of life among relapsing multiple sclerosis patients while reducing the number of relapses, according to new analyses of previously unpublished data from clinical trials assessing the drug. This new data, published in the Multiple Sclerosis Journal, come just as the European Commission ponders whether to approve the once- rejected therapy to treat relapsing forms of MS. Its decision is expected later this month, seven years after a perceived increased of cancer risk led the European Medicines Agency (EMA) to block Mavenclad. In 2011, the U.S. Food and Drug Administration (FDA) rejected the medication, forcing its eventual withdrawal from the Australian and Russian markets, where it had already been licensed. For the study, researchers at Queen Mary University of London used data obtained from the EMA through a Freedom of Information request. They analyzed data from the Phase 3 CLARITY trial, which compared Mavenclad to placebo. The trial's 1,326 participants completed a quality-of-life questionnaire that focused on disease aspects such as mobility, self-care, usual activities, pain or discomfort, and anxiety. After two years, those on Mavenclad had significantly improved their quality of life compared to the control group, particularly in terms of self-care. Mavenclad also helped mobility, which might be related to its ability to prevent relapses and delay progression, researchers said. While researchers assessed quality of life using two different questionnaires, patients had only completed one in sufficient numbers to allow for a solid analysis. The other quality-of-life tool provided researchers with numerically positive results, but the low number of responses made the result difficult to interpret. This wasn't the first time QMUL researchers have contributed in this way to knowledge of Mavenclad in MS. In 2015, they used a Freedom of Information request to obtain data showing that Mavenclad was not related to increased cancer risk. āCladribine seemed to have such excellent potential as a treatment for MS that we thought it was tragic the development program was shelved, and significant parts of the clinical trial data remained unpublished,ā study leader Klaus Schmierer, a neurologist at both QMUL and Barts Health NHS Trust, said in a press release. āIn addition to the drug being highly effective, well tolerated and safe as far as short-term studies can show, we now know it also improves patientsā quality of life. The new results seemed so clear, we felt it was extremely important to publish and share these data." Mavenclad has now been studied in some 2,700 patients with relapsing MS in the Phase 3 trials CLARITY, CLARITY EXTENSION, and ORACLE-MS, as well as the Phase 2 ONWARD trial, and the ongoing long-term study PREMIERE. The treatment differs from most other oral MS therapies in that a short treatment course ā a maximum 20 days ā triggered effects that were upheld for two years. Studies of Mavencladās mechanisms suggest the drug gets such results by resetting the immune system. In June 2017, the EMA's Committee for Medicinal Products for Human Use urged the European Commission to approve Mavenclad. Merck also plans to seek U.S. approval for its therapy and is now in talks with the FDA about Mavenclad's future.
July 11, 2017 News by Patricia Silva, PhD Europe Restricts Use of MS Therapy Zinbryta After Liver Damage Cases and a Death The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…
June 27, 2017 News by Alice MelĆ£o, MSc Cladribine Tablets Are Only a Step Away from European Union Approval for Relapsing Multiple Sclerosis MerckāsĀ cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human UseĀ has recommended that the European Commission approve theĀ tablets. āThe positive opinion from the CHMPĀ [the committee] is an extraordinary…
March 30, 2017 News by Patricia Silva, PhD Hope, But No Cheers Yet, Voiced by MS Groups in Europe and Canada Waiting on Own Ocrevus Decision American patient groupsĀ and neurologists haveĀ clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. But what is happening elsewhere in regard to this firstĀ treatment for both primary progressive and relapsing multiple sclerosis (MS)?…
June 2, 2016 News by Ćzge Ćzkaya, PhD MS Drug Tysabri (Natalizumab) Gets Positive Opinion from European Medicines Agency Biogen, announced that TYSABRI, a drug developed to treat people with multiple sclerosis (MS) has received a positive opinion from the European Medicine Agency (EMA) recommending its approval to be used in people with elapsing-remitting multiple sclerosis (RRMS).