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 spasticity in people with multiple sclerosis (MS). The strawberry-flavored formulation, developed by 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 either clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (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 approved Novartis’ Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms of 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…

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 with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…

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) 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…

May 13, 2019 News by Joana Carvalho, PhD

Ocrevus Approved in UK as First NHS Treatment for PPMS

After first 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…

March 1, 2018 News by Alice Melão, MSc

Argentina Approves Mavenclad for Active Relapsing MS

Argentina has become the first country in Latin America to approve Mavenclad (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and Medical Technology's approval covered Merck’s 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. Raúl 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, head of the institute's neuroimmunology and demyelinating diseases department. Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MS 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 2,700 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."

January 15, 2018 News by Patricia Silva, PhD

European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU

The European Commission has approved Roche’s Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commission’s move —  nearly 10 months after the U.S. Food and Drug Administration (FDA) approved Ocrevus in March 2017 — makes it the first approved PPMS…

December 11, 2017 News by Alice Melão, MSc

Australia Approves Shorter Mavenclad Treatment Regimen for Relapsing-Remitting MS

Australia has approved a shorter treatment regimen of Merck’s Mavenclad 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 the therapy. Health Canada and the European Commission 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,” Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. “As 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 targets immune cells that trigger relapsing MS. Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibits 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-MS 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 progression 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 Melão, MSc

Health Canada Approves Merck’s Mavenclad to Treat RRMS

Canadians with relapsing-remitting multiple sclerosis can now receive Merck’s Mavenclad, now that Health Canada 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 drug’s 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 promotes 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 rates 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 Melão, MSc

Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS

Europeans with relapsing multiple sclerosis (MS) and early primary progressive MS are one step closer to accessing Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion — announced in a press release issued Nov. 10 by the EMA’s Committee for Medicinal Products for Human Use — 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 whether Ocrevus 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, any decisions on price or insurance reimbursements will be the responsibility of each member state. Ocrevus won U.S. approval earlier this year. It was also recently approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division of 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 Serono’s 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.

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'd 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 — an antibody that targets B-cells with the surface factor CD20 — 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.

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