relapsing MS

The U.S. Food and Drug Administration has approved a new dose of Sandoz’s multiple sclerosis therapy Glatopa (glatiramer acetate injection) that is twice as large as the currently authorized one. Regulators’ approval of the 40 mg/mL applies to people with relapsing forms of MS. A mg/mL designation refers to the concentration of…

Changing from injectable disease-modifying therapies (DMTs) to Gilenya (fingolimod) can benefit people with relapsing multiple sclerosis (MS), regardless of prior therapy regimens. The PREFERMS Phase 4 trial (NCT01623596) concluded that Gilenya, marketed by Novartis, reduces annualized relapse rates (ARR) and brain volume loss (BVL) in both…

The U.S. Food and Drug Administration has given fingolimod a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. Novartis is marketing it in the United States under the brand name Gilenya for adults with relapsing MS. It has yet to approved…

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.

Ozanimod (RPC1063) was seen to lower relapse rates and reduce brain and spinal cord lesions among patients with relapsing multiple sclerosis (MS) participating in a Phase 3 study of the treatment. Giancarlo Comi, from the Vita-Salute San Raffaele University, in Italy, announced the results in a presentation during the ongoing…

TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio…

Sanofi Genzyme will discuss three of its multiple sclerosis therapies at the American Academy of Neurology annual meeting in Boston, April 22-28. The presentations will cover two approved treatments for relapsing MS – Lemtrada (alemtuzumab) and Aubagio (teriflunomide) – and one that has been in a Phase 1 clinical…

Texas firefighter Wayne Donovan is among the estimated 250,000 to 350,000 Americans with multiple sclerosis (MS). He enrolled in a clinical trial testing Ocrevus (ocrelizumab), which the  U.S. Food and Drug Administration recently approved as the first therapy for both relapsing and primary progressive forms of MS. Donovan was diagnosed in 2011 at…

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has cleared its initial doubts and now recommends Zinbryta (daclizumab) to treat relapsing multiple sclerosis (MS) in England and Wales. NICE had initially rejected Zinbryta after a first stage of the drug’s review process, due to some issues linked to…

There is now less than a month until the U.S. Food and Drug Administration (FDA) is expected to approve Ocrevus, generic name ocrelizumab, for use as a therapy for multiple sclerosis. Clinical trials have shown Genentech’s drug to be a promising therapy for relapsing MS and, significantly,…

Spending more time in the sunshine could make people with multiple sclerosis (MS) feel more energetic, though dietary vitamin D intake’s effect is mixed, depending on what type of MS a particular patient has. That’s the conclusion of a study — “Dietary intakes of vitamin D, sunshine exposure, EDSS and fatigue…

A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients with relapsing multiple sclerosis (RMS) shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported. The Phase 3 SUNBEAM trial (NCT02294058) tested ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to…

Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., is now dispensing the limited-distribution drug Zinbryta (daclizumab) as a therapy for relapsing multiple sclerosis (MS). Zinbryta was recently approved by the U.S. Food and Drug Administration (FDA), and is indicated for the treatment of adult patients with relapsing MS.

Biogen and AbbVie announced that the drug Zinbryta (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most of Europe for adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. “Clinical data showed Zinbryta significantly reduced relapses, 24-week…

Genentech, a member of the Roche Group, was founded more than 35 years ago and has been focused on a variety of research fields, including cancer, immunology, neurodegenerative disorders, metabolic diseases, and infectious diseases. Genentech has been committed to discovering and developing new medicines for patients with major diseases of the nervous…

Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…