Australia

Roche has teamed up with researchers in Australia to study the immune and biological mechanisms leading to better outcomes for multiple sclerosis (MS) patients who are or have been pregnant. The four-year project, led by Vilija Jokubaitis, PhD, a neuroscientist and group leader at Monash University, is expected…

Australia’s National Health and Medical Research Council (NHMRC) is giving a total of AU$6.75 million (about $5 million) in grants to advance research into multiple sclerosis (MS), including risk factors for the disease, preventing falls, and harnessing viral-immune system interactions to improve patients’ lives. The three investigator grants,…

The Accessible Product Design Alliance has released a statement calling for changes in products and packaging design to assure equal accessibility among consumers, including those with disabling disorders such as multiple sclerosis (MS). Composed of 11 nonprofit health consumer organizations in Australia and New Zealand — including MS…

A search is on for an anti-inflammatory treatment targeting the C-reactive protein — CRP, a biomarker of inflammation produced by the liver — of possible use in a wide variety of conditions, including immune-mediated diseases such as multiple sclerosis (MS). Researchers at the Baker Heart and Diabetes Institute and the…

A “prudent” diet rich in fresh fruit, non-fried fish, whole grains, vegetables, and nuts may lower the likelihood of a relapse in people with a first demyelinating event, a major risk factor for multiple sclerosis (MS), a study in Australia suggests. While the researchers did not find a strong link…

Novartis’s Mayzent (siponimod) has been approved by Australia’s Therapeutic Goods Administration (TGA) for the treatment of secondary progressive multiple sclerosis (SPMS), making it the first therapy to be approved for this use in Australia. SPMS is a form of MS that develops after the onset of…

Bladder and bowel problems, such as constipation and fecal incontinence, are associated with a higher level of fatigue in people with multiple sclerosis (MS), according to a study in Australia. The findings also showed that greater fatigue and experiencing bowel and bladder problems are associated with…

There is a need for better diagnosis and treatment management of comorbidities — simultaneously occurring disorders — in people with multiple sclerosis (MS), as shown by the impact these additional health issues have on patients’ health-related quality of life, according to a new report. The data was presented by Lara…

Australia was one of the first countries to approve the use of Mavenclad (cladribine tablets, 10 mg) to treat patients with highly active relapsing-remitting multiple sclerosis (RRMS). Now, the country’s government has taken another step to ensure this 20-day course treatment is available to the largest number possible of people affected by the disease. Australia’s Prime Minister, Hon. Scott Morrison MP, announced that Merck KGaA’s therapy was included on the Pharmaceutical Benefits Scheme (PBS) listing effective Jan. 1. This will make Mavenclad affordable for about 6,200 patients each year who are already accessing PBS-subsidized medicines for MS. (Of note, Merck KGaA is known as EMD Serono in the U.S. and Canada.) This was made possible by the joint effort of MS Australia, MS Research Australia, clinicians and members of the MS community who, after successive submissions, achieved a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list Mavenclad on PBS as a treatment for RRMS. Australia's government will cover almost all costs of Mavenclad, which will mean that patients will have to pay only $40.30 per prescription, or $6.50 for concessional patients. “Thanks to our strong economic management, we’ve ensured that every new, essential medicine recommended for listing by the Pharmaceutical Benefits Advisory Committee receives government subsidy to make it affordable for all Australians,” the Prime Minister said in a press release. Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps MS patients remain relapse-free for up to four years, while supporting the “reset” of the immune system. Australia's regulatory agency decided to approve Mavenclad based on the findings of a number of clinical trials, including the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, as well as the Phase 2 trial ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) trials. These clinical studies involved more than 2,700 RRMS patients, some of whom were followed for more than 10 years. Overall, the trials showed that Mavenclad significantly reduced relapse rates, disability progression, and brain atrophy. Doctors recommend the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments.

Health professionals are often not discussing the importance of following national dietary guidelines with their multiple sclerosis (MS) patients, causing them to turn to other sources like the internet that may advise potentially harmful diets with serious consequences, according to an Australian study. The study, “Dietary responses to…

Most general practitioners in Australia favor prescribing medical cannabis to treat spasticity in multiple sclerosis (MS) or pain in select other diseases, but are not allowed to under current laws and say they know little about its use, according to results of a national survey. A study based on its…

The United States and Australia have issued patents on Sonde Health‘s voice-analysis technology for diagnosing and monitoring multiple sclerosis and other diseases that affect speech. Sonde, which has dubbed its invention vocal biomarker technology, said the U.S. patent is  9,936,914 and the Australian one 2014374349. Both patents cover Sonde’s…

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."

Two companies that plan a huge cannabis-growing and research facility in Australia have applied for licenses to run the operations, whose products could benefit multiple sclerosis patients. MYM Nutraceuticals and PUF Ventures Australia asked the Australian Office of Drug Control for both medical cannabis and cannabis research licenses. The applications come at…

Flex Pharma has completed enrolling multiple sclerosis patients in a Phase 2 clinical trial in Australia testing FLX-787’s ability to alleviate muscle stiffness, spasms, and cramps. The compound has a mechanism of action that Flex believe will generate fewer side effects than other muscle-relaxing medications. The company is also…

The numbers of people being diagnosed with multiple sclerosis is rising worldwide, though distinct differences in factors thought to drive this rise are evident among regions, according to MS data represented by researchers on patients in Asia, Latin America, and the Australia-New Zealand. The data was part of the session “Prevalence and…

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. “We 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,” Dr. Sandra Horning, Roche’s chief medical officer and head of global product cevelopment, said in a press release. “Approval 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 — 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. “People 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 — 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 drug’s B-cell depleting actions play out to harness MS disease processes.

American patient groups and neurologists have 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 first treatment for both primary progressive and relapsing multiple sclerosis (MS)?…

Australians living with multiple sclerosis (MS) don’t have adequate access to dental care, a new study reports. The study, “How do Australians living with MS experience oral health and accessing dental care? A focus group study,” appeared in the journal Community Dentistry and Oral Epidemiology. MS is an autoimmune…

A specialty shoe insole that may help multiple sclerosis (MS) patients walk and go about their daily lives with more assurance and ease was developed by an Australian-led research team, which is now seeking 176 patients to test the insole in a three-month trial. The study is led by Anna Hatton, a physiotherapy professor…

Do you have any strong feelings about worms? No, not earthworms you find in the garden, or even roundworms or tapeworms that can sometimes be found in animals and humans. What I am talking about is purposely being infected with parasitic worms. OK, it may not be as gross as…

Flex Pharma, Inc., announced the start of a Phase 2 clinical trial assessing the safety and efficacy of FLX-787 in multiple sclerosis (MS) patients who suffer from cramps, spasms, and/or spasticity as a result of the disease. The trial is being run in conjunction with Neuroscience Trials Australia. Flex Pharma’s FLX-787 is a single molecule,…

Innate Immunotherapeutics, Ltd., announced that it has completed patient enrollment in its ongoing Phase 2B, placebo-controlled clinical trial assessing the efficacy and safety of the drug MIS416 as a once-weekly treatment for secondary progressive multiple sclerosis (SPMS). MIS416 is a biologically derived immune modulator that targets myeloid cells, a subset of innate immune cells that can…

Next Sunday, November 2nd, Sydney, Australia will hold one of the country’s largest fundraising events to support multiple sclerosis research and advocacy, the MS Gong Ride, a one day community bike ride designed to collect $3.8 million. Each biker is asked to help raise $250 for the historic ride that celebrates its…

Australian authorities are alerting Multiple Sclerosis patients to the risk of unproven stem cell treatments that are being performed both in the country and overseas, after the recent death of a woman in Russia undergoing a controversial treatment for the disease. The continued marketing campaigns to…

Group exercise could be very beneficial in improving the health of multiple sclerosis patients, according to Sheila Lennon, Physiotherapy Professor from Flinders University, in Adelaide, Australia. Lennon is the creator of a new training manual for clinicians, as she advocates the need for regular and ongoing physiotherapy in the public health system.