September 28, 2023 News by Andrea Lobo, PhD Tyruko, first Tysabri biosimilar, approved in Europe for RMMS The European Commission has approved Tyruko (natalizumab), the first biosimilar of Tysabri, for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The approval makes Tyruko available in the European Union for the same indication as its reference medicine. It also marks the first approval…
December 9, 2021 News by Patricia Inacio, PhD FDA Approves Lyvispah, Granular Form of Baclofen, to Treat Spasticity The U.S. Food and Drug Administration (FDA) has approved Lyvispah, a dissolvable granular formulation of baclofen, to treat spasticityĀ in people withĀ multiple sclerosis (MS). The strawberry-flavored formulation, developed byĀ Saol Therapeutics, is particularly suitable to ease flexor spasticity, the involuntary bending of the knees and hips toward the…
July 14, 2021 News by Marta Figueiredo, PhD Kesimpta for RRMS Now Available in Scotland at Low or No Cost Adults in Scotland with active relapsing-remitting multiple sclerosis (RRMS) will now have access at low or no cost to Kesimpta (ofatumumab), the first self-administered, at-home B-cell-targeting therapy for people with the neurodegenerative disease. The Scottish Medicines Consortium (SMC) recommended that the Novartis therapy be available through the…
April 19, 2021 News by Patricia Inacio, PhD Kesimpta Approved in UK as At-home Relapsing MS Therapy Kesimpta (ofatumumab) has been approved in the U.K. as the first self-administered, at-home, B-cell-targeting therapy for people with relapsing forms of multiple sclerosis (MS) and active disease. More specifically, the approval includes patients with eitherĀ clinically isolated syndrome,Ā relapsing-remitting MSĀ (RRMS), or active secondary progressive MSĀ (SPMS), who have…
March 30, 2021 News by Marta Figueiredo, PhD Kesimpta Approved in EU as At-home Injectable Therapy for Relapsing MS The European Commission has approvedĀ Novartisā Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms ofĀ multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…
October 15, 2020 News by Forest Ray PhD Mayzent Approved for Active Secondary Progressive MS in Scotland The Scottish Medicines Consortium (SMC) has approved Mayzent (siponimod) for the treatment of active secondary progressive multiple sclerosis (SPMS) in Scotland. Mayzent, developed by Novartis, is a tablet taken once daily to counter a person’s disability progression. SPMS gradually develops from relapsing-remitting MS, and is…
October 8, 2020 News by Sara Guariglia FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment Lupin‘s generic equivalent ofĀ Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment ofĀ multiple sclerosis (MS), the company announced in a press release. The therapy ā dimethyl fumarate delayed-release capsules ā is indicated for use in people withĀ clinically…
August 21, 2020 News by Marisa Wexler, MS FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those withĀ clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…
May 27, 2020 News by Marisa Wexler, MS Zeposia Receives European Commission Approval for Adults with Active RRMS The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features. The EC decision follows a positive opinionĀ issued in March by the EuropeanĀ Committee for Medicinal Products for Human Use (CHMP).
February 21, 2020 News by Iqra Mumal, MSc Flowonix’s Prometra II Pump System Receives FDA Approval for Use with Intrathecal Baclofen The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix MedicalāsĀ Prometra II Programmable Pump System for use with intrathecal baclofenĀ for the treatment of spasticity across numerous conditions, including multiple sclerosis. Intrathecal baclofen ā sold asĀ Gablofen by Piramal,Ā Lioresal by…
January 21, 2020 News by Marta Figueiredo, PhD Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS TheĀ European CommissionĀ has approvedĀ Novartis‘s MayzentĀ (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosisĀ (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. āAs the only indicated oral therapy proven for…
December 6, 2019 News by Joana Carvalho, PhD FDA Approves Three Generic Versions of Novartis’ Gilenya for Treating Relapsing MS The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…
October 30, 2019 News by Patricia Inacio, PhD Vumerity Approved in US as Treatment for RRMS and Active SPMS The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate)Ā for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…
June 25, 2019 News by Ana Pena PhD FDA Approves Botox to Treat Upper Limb Spasticity in Children Aged 2 to 17 The U.S. Food and Drug Administration (FDA) has approved the use of Botox (onabotulinumtoxinA), marketed by Allergan, for the treatment of children ages 2 to 17 with upper limb muscle stiffness or spasticity, a common symptom inĀ children with…
May 13, 2019 News by Joana Carvalho, PhD Ocrevus Approved in UK as First NHS Treatment for PPMS After firstĀ rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now approved the use of Ocrevus (ocrelizumab) for people in the U.K. with early, inflammatory primary progressive multiple sclerosis (PPMS). This means that PPMS patients living in the…
April 1, 2019 News by Joana Carvalho, PhD FDA Approves EMD Serono’s Mavenclad as Treatment for RRMS and Active SPMS The U.S. Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) andĀ active secondary progressive disease (SPMS). Up to 85 percent of people with MS are initially diagnosed…
March 27, 2019 News by Patricia Inacio, PhD FDA Approves Novartis’ Mayzent for Relapsing Forms of Multiple Sclerosis, Including Active SPMS The U.S. Food and Drug Administration (FDA) has approved Novartis’ Mayzent (siponimod) oral tablets for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS). Mayzent was designed to inhibit 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…
November 30, 2018 News by Alice MelĆ£o, MSc Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…
March 1, 2018 News by Alice MelĆ£o, MSc Argentina Approves Mavenclad for Active Relapsing MS Argentina has become the first country in Latin America to approve MavencladĀ (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and Medical Technology's approval coveredĀ Merckās cladribine tablet formulation. Merck expects to make the treatment available in the country in the next few months. Mavenclad has already been approved in Canada, Australia, Israel, and Europe. Merck is seeking approval in the United States and other countries. "Having a new MS treatment approved in Argentina is very motivating," Dr. Jorge Correale of the Institute for Neurological Research Dr. RaĆŗl Carrea said in a press release. "Mavenclad allows the patient's immune system to go through a selective immune reconstitution, similar to a reset, and the treatment mechanism is simple because it does not require frequent administration or monitoring," said Correale,Ā head of the institute's neuroimmunology and demyelinating diseases department. Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MSĀ without suppressing the entire immune system. With a maximum of 20 days' treatment over two years, the oral drug promotes long-term inhibition of harmful immune cells, reconstituting the immune system. MS is an autoimmune disease, or one in which the immune system attacks normal tissue as well as invadors. Argentine regulators based their approval on the results of five clinical trials. These were the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS studies, the Phase 2 ONWARD study, and the long-term PREMIERE study. These trials involved more than 2,700Ā patients with relapsing MS, some of whom researchers followed for more than 10 years. The trials showed that Mavenclad can significantly reduce MS relapse rates, disability progression and brain atrophy. The treatment is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. "We are pleased the Argentinian Administration of Medicines, Food and Medical Technology has approved Mavenclad," said Rehan Verjee, the chief marketing and strategy officer of Merck's biopharma business. "Our goal is to ensure fast access to patients who may benefit from this innovative therapy, and we will be working with payers on obtaining reimbursement as a next step."
February 16, 2018 News by Alice MelĆ£o, MSc Health Canada Approves Ocrevus to Treat Early Stage PPMS Patients with Active Disease Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), followingĀ Health Canada‘s decision to approve its use with restrictions. Roche/Genentechās Ocrevus can be prescribed to adults with early-stage PPMS and characteristic signs of…
February 15, 2018 News by Patricia Silva, PhD FDA Approves Dose of MS Therapy Glatopa That Is Twice as Large as Current One The U.S. Food and Drug Administration has approved a new dose ofĀ Sandozās multiple sclerosis therapyĀ Glatopa (glatiramer acetate injection)Ā that is twice as large as the currently authorized one. Regulators’ approval of theĀ 40 mg/mL applies to people with relapsing forms of MS. A mg/mL designation refers to the concentration of…
January 15, 2018 News by Patricia Silva, PhD European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU The European Commission has approved Roche’sĀ Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commissionās move ā Ā nearly 10 months after the U.S. Food and Drug Administration (FDA)Ā approvedĀ Ocrevus in March 2017 ā makes it the first approved PPMS…
December 11, 2017 News by Alice MelĆ£o, MSc Australia Approves Shorter Mavenclad Treatment Regimen for Relapsing-Remitting MS Australia has approved a shorter treatment regimen ofĀ MerckāsĀ MavencladĀ for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on theĀ therapy. Health CanadaĀ andĀ the European CommissionĀ approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,ā Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. āAs an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targetsĀ immune cells that trigger relapsing MS.Ā Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibitsĀ harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MSĀ studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progressionĀ and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."
December 6, 2017 News by Alice MelĆ£o, MSc Health Canada Approves Merck’s Mavenclad to Treat RRMS Canadians with relapsing-remitting multiple sclerosis can now receiveĀ Merckās Mavenclad, now thatĀ Health CanadaĀ has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world's highest MS rate. This follows the drugās approval by the European Commission in August, making Mavenclad Europe's first approved highly efficient, oral short-course therapy for relapsing MS. Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States. Mavenclad was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotesĀ long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system. Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY, CLARITY EXTENSION and ORACLE-MS; the Phase 2 trial ONWARD study ; and the long-term study PREMIERE. These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years. Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse ratesĀ and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.
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.
October 9, 2017 News by Alice MelĆ£o, MSc In Blow to Teva, EU Approves Synthonās Generic Version of Copaxone to Treat RRMS Synthonās prefilled syringe with 40 mg/ml of glatiramer acetate ā the generic version of Teva Pharmaceuticalās Copaxone 40 mg ā has received regulatory clearance in all 28 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis (RRMS). The low-dose…
September 29, 2017 News by Patricia Silva, PhD Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'dĀ in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus āĀ an antibody that targets B-cells with the surface factor CD20 āĀ was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.
August 29, 2017 News by Patricia Silva, PhD Merckās Mavenclad, an Oral Therapy for Relapsing MS, Approved in European Union The European Commission has approved Merck KGaAās Mavenclad (cladribine tablets)Ā to treatĀ highly active relapsing forms of multiple sclerosis (MS).Ā The Aug. 25 decision in Brussels marks the first approval of a highly efficient oral short course therapy for MS in Europe. Mavenclad has been shown to harness disease activity for…
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.