July 18, 2017 News by Patricia Silva, PhD Australian Authorities Approve Ocrevus Following U.S. Endorsement of Breakthrough MS Therapy Australia has become the first country to approve Genentech's Ocrevus for relapsing and primary progressive multiple sclerosis treatment since the therapy's initial approval by the U.S. Food and Drug Administration in March 2017. The Australian Therapeutic Goods Administration gave Ocrevus the green light on July 17, filling an unmet need for Australia's estimated 23,000 MS patients. āWe are pleased that another regulatory body recognized for its rigorous review process has approved Ocrevus with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,ā Dr. Sandra Horning, Rocheās chief medical officer and head of global product cevelopment, said in a press release. āApproval in Australia is significant because of the high prevalence of MS in the country, making it the leading cause of non-traumatic disability in young adults." The drug's developer, Genentech, and Genentech's parent company Roche have submitted applications to get Ocrevus approved in more than 50 countries in Europe, Latin America and the Middle East. Ocrevus trials showed that, among relapsing patients, relapse rates were nearly halved compared to those treated with Rebif. Many of these patients also reached a level of no disease activity ā measures that Genentech has continued to explore after the drug's U.S. approval. In addition, data also showed that PPMS patients, who deteriorate more rapidly, benefit from Ocrevus treatment. āPeople with PPMS [primary progressive multiple sclerosis], who often experience faster and more severe disability, have not had any approved treatment until Ocrevus," Horning said. "We continue to work closely with regulatory authorities across the world to bring Ocrevus to people with multiple sclerosis as soon as possible." Ocrevus is an antibody that blocks the CD20 molecule on certain immune B-cells. Researchers believe these cells directly damage myelin ā the protective coat that insulates nerve cells in the brain and spinal cord. Evidence also indicates that B-cells can directly damage neurons themselves. The drug continues to be evaluated in a range of clinical trials, including one that specifically focuses on how the drugās B-cell depleting actions play out to harness MS disease processes.
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…
May 25, 2017 News by Patricia Silva, PhD Fampyra Granted Standard Approval in Europe as Trial Results Support Effectiveness Fampyra (prolonged-release fampridine tablets) ā sold in the U.S. as Ampyra (dalfampridine) ā has now been granted standard marketing authorization in Europe. The approval was based on the results of a Biogen-sponsored Phase 3 clinical trial confirming the drugās safety and efficacy in improving walking in patients with multiple…
April 6, 2017 News by Patricia Silva, PhD ‘Adequate and Rapid Delivery’ of Ocrevus Expected, Says Genentech Director in Interview Ocrevus (ocrelizumab),Ā now approved for both relapsing and primary progressive multiple sclerosis (MS), is expected to become available in the coming week. While patients and neurologists are waiting, Multiple Sclerosis News Today spoke to Genentech about the treatment’s approval, future research plans, and what patients can expect in terms…
April 5, 2017 News by Joana Fernandes, PhD UCSF Neurologist Played Key Role in MS Research Turning to B-Cells, Essential Step to Ocrevus Dr. Stephen Hauser, chair of the neurology department at the University of California San Francisco, was instrumental in the early research and laterĀ clinical trials that ultimately led toĀ Ocrevus (ocrelizumab), the first therapyĀ approved by the U.S. Food and Drug Administration (FDA)Ā for bothĀ relapsing MSĀ (RMS) and primary progressive multiple sclerosis…
April 4, 2017 News by Patricia Silva, PhD Transcript of Interview with Dr. Robert Lisak, a Neurologist and MS Expert, About Ocrevus Here is a transcript of the Multiple Sclerosis News Today interview about Ocrevus (ocrelizumab) with Dr. Robert Lisak of the Consortium of Multiple Sclerosis Centers (CMSC). Lisak, a professor of neurology and of immunology and microbiology at Wayne State University School of Medicine, is aĀ former…
April 4, 2017 News by Patricia Silva, PhD Ocrevus Holds Promise, But Needs to Prove Itself in ‘Long Term,’ Says Dr. Robert Lisak with CMSC Interest inĀ Ocrevus (ocrelizumab), the first FDA-approved treatment for bothĀ relapsing and primary progressive multiple sclerosis, isĀ running high among patients and the organization representing them ā as, arguably, are expectations ofĀ its use. But how do physicians involved in MS care view the newcomer? Dr. Robert Lisak (Photo courtesy…
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)?…
March 29, 2017 News by Patricia Silva, PhD Excitement to Cautious Optimism ā Reactions to Approval of Ocrevus TheĀ historic approval of Ocrevus (ocrelizumab), the first-ever treatment for primary progressive multiple sclerosis (MS), set off ripples in the relatively calm waters of MS news reporting. The drug, which was also approved Tuesday as an unusually effective and safe treatment for relapsing MS, is viewed as a game-changer…
March 16, 2017 Columns by admin After Long Wait, Zinbryta Gains Approval in Areas of the UK News that daclizumab, brand name Zinbryta, has been given the go-aheadĀ to be available through the U.K.ās National Health Service (NHS) for treating relapsing MS, at least in part of the country, is good news. But why has the decision taken…
October 4, 2016 News by Patricia Silva, PhD NICE Planning to Reject MS Treatment, Zinbryta, in England and Wales TheĀ National Institute for Health and Care Excellence (NICE), the health authorityĀ for England and Wales,Ā has decided not to recommend Zinbryta (daclizumab)Ā be made available to multiple sclerosis (MS)Ā patients through the country’s health service. The decision came in a first stage of the drugās review process, and NICE is welcoming…
May 31, 2016 News by Patricia Silva, PhD Multiple Sclerosis treatment Zinbryta (Daclizumab) Approved by FDA Zinbryta (daclizumab) was approved May 27 for the treatment of adults with relapsing multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) cleared Biogenās new long-acting injection as a patient self-administered monthly therapy. The director of Neurology Products at the U.S. FDAās Center for Drug Evaluation…