Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the two-year Phase III REFLEX 1 study met its primary endpoint by demonstrating that Rebif(R) (interferon beta-1a) significantly delayed conversion to multiple sclerosis (MS) diagnosed according to the McDonald criteria 2 in patients with a first clinical event suggestive of the disease.
The international REFLEX study with 517 patients was conducted with the serum-free formulation of Rebif(R) 3, which was first introduced in 2007 and is now available in all European Union countries, Australia, Canada and Switzerland, as well as a number of countries in Asia, Latin America, Africa and the Middle East. The serum-free formulation of Rebif(R) is currently not available in the United States.
The risk of conversion to MS (McDonald criteria) over two years was reduced by 51% (p<0.00001) in patients who received Rebif(R) 44 mcg three times a week compared to placebo. A risk reduction of 31% (p=0.008) compared to placebo was observed in patients who received once-weekly administration of Rebif(R) 44 mcg. The probability of conversion to MS (McDonald criteria) over two years was 86% in the placebo group, 62% in patients who received Rebif(R) 44 mcg three times a week and 76% in patients who received once-weekly administration of Rebif(R) 44 mcg.
More details on this study
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ECTRIMS (European Committee for Treatment and Research In Multiple Sclerosis) hosts the world’s largest conference devoted to basic and clinical research in MS.
This year’s meeting took place in Gothenberg from 13-16 October and featured a wide range of presentations, posters and reports of new and ongoing research.
Below are brief reviews of some of the research reported.
ECTRIMS round up | News | MS Trust – Information, education, research and support
Posted in ABCR (Avonex, Betaferon, Copaxone, Rebif), CCSVI, Research, Tysabri| Posted by Admin | Comments Off
Talking about Medical News: ECTRIMS: Glatiramer Acetate Beats Interferon for MS Fatigue – in Meeting Coverage, ECTRIMS from MedPage Today
Glatiramer acetate (GA) reduces fatigue in multiple sclerosis patients more than interferon beta-1b (IFN-1b) after 1 year of treatment, according to a new study.
IFN-1b had no impact on two clinical measures of fatigue, while GA (Copaxone) reduced the score on the Fatigue Severity Scale (FSS) by 20%, and the score on the Fatigue Descriptive Scale (FDS) by 34%, according to a study presented here at the European Committee for Treatment and Research in Multiple Sclerosis meeting.
Based on the results, the authors, Tatiana Shmidt and a colleague at the Kozhevnikov Clinic for Neurological Diseases in Moscow, Russia, concluded in their poster, “Copaxone is recommended as a first-line imunomodulating drug for patients with severe fatigue.” The authors were unavailable for comment at press time.
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Merck Serono to Introduce RebiDose(TM), the Rebif(R) Single Use Pre-filled Pen for Treatment of Multiple Sclerosis
“We are pleased to extend our range of devices with RebiDose(TM to meet the needs of patients looking for simple and minimum injection preparation,” said Roberto Gradnik, Head of Global Business Unit Neurodegenerative Diseases at Merck Serono. “The introduction of RebiDose, alongside RebiSmart, which was launched last year, underscores our commitment to improve the treatment convenience of multiple sclerosis patients, by offering them different options to suit their individual injection needs.”
RebiDose was specifically designed to provide MS patients with a quick and simple device. This pre-filled injection device may also be ideal for patients who are traveling. RebiDose used with Rebif will be available in a monthly pack in two different doses -22 micrograms and 44 micrograms – and in a titration pack including two different doses -8.8 micrograms and 22 micrograms. RebiDose has been approved in the European Union and in Australia. It will be launched on a country-by-country basis, with first launches planned by the end of the year.
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Six Thousand Metres a Day for 12 Years | British Rowing
72 year old Keith Atkinson, President of Nottingham Rowing Club, has just completed rowing 30 million metres on the rowing machine. It has taken him 12 years – the equivalent of rowing over 6 thousand metres every day! Here is his inspiring story:
When I began in December 1997″, explained Keith “I had two main objectives. One was to learn as much as possible about the machine as my wife and I were part of the newly-formed Concept 2 Education Team. The other was to maintain my aerobic fitness level. I had been diagnosed with Multiple Sclerosis which was making walking increasingly difficult, so sitting down and exercising was a good option. More by accident than design, I settled into 2 million metres a year pattern. In 1999 and 2000 I was fortunate to race at the World Indoor Rowing Championships in Boston #Massachusetts# where I won the bronze medals in the over-65 Lightweight category.
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Talking about Novartis Gilenya MS Pill to Cost $48,000 a Year – Bloomberg
Novartis AG’s multiple sclerosis pill Gilenya will cost $4,000 a month in the U.S., according to a company spokesman.
Novartis has set a wholesale price at about $48,000 annually, Eric Althoff, a spokesman for the Basel, Switzerland- based company, said by e-mail. The company has programs to help patients with the cost of the drug, he said.
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Talking about MS Society of Canada – Treatment Notes (short updates, focused on news affecting MS treatment)
Health Canada has approved Sativex® [delta-9-tetrahydrocannabinol 27 mg/mL (from Tetrabinex® – cannabis sativa L. extract – Bayer Inc.) as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis. In 2005 Sativex® was approved for as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis. Canada is now the third major country to approve Sativex® for symptomatic relief of spasticity in adult patients with MS.
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UPDATE: Elan: Test Results Could Help Determine PML Risk – WSJ.com
DUBLIN (Dow Jones)–Elan Corp. PLC (ELN) Tuesday announced results of a test that could help determine whether multiple sclerosis patients will develop a rare brain disease before they decide to take Elan and joint venture partner Biogen Idec Inc.’s (BIIB) drug Tysabri.
According to research, samples from 17 patients were analyzed and shown to contain the JC Virus or be “anti-JCV antibody positive.” All 17 patients subsequently went on to contract the rare brain disease, known as PML, which means they wouldn’t have been good candidates for Tysabri.
About 50% of the population are thought to carry the JC Virus and Tysabri patients who don’t have the virus are thought to be at significantly lower risk of PML. The brain disease occurs when the virus attacks the central nervous system in people who have weakened immune systems.
“These data support our ongoing clinical studies to assess the clinical utility of this assay and our commitment to further mitigating the rare risk of PML in Tysabri-treated patients,” said Alfred Sandrock, senior vice president of neurology research and development at Biogen Idec Inc. (BIIB).
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The Associated Press: FDA weighs benefits, risks of Novartis MS pill
Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia to treat patients with relapsed multiple sclerosis, which causes tremors and movement problems. The drug is a daily pill and would offer an alternative to older injectable drugs.
FDA reviewers said two studies of the drug “provide substantial evidence for an effect.”
However, FDA staff also noted a number of side effects with the drug, including eye disorders, heart problems and weakened lung function.
Serious side effects occurred in at least 8.5 percent of patients taking Novartis’ drug, compared with 5.8 percent of patients taking older multiple sclerosis drugs.
FDA reviewers complained that there was little data on the long-term effects of using Gilenia.
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Talking about UK scheme for MS drugs a costly failure -experts | Reuters
“The scheme was a success for the drug companies, who sold at close to full price to the NHS,” said James Raftery, a professor of health technology assessment at Southampton University. “For the NHS, however, the scheme can be judged only a costly failure.”
Raftery said an assessment of the scheme in 2009 by its scientific advisory group, which included the drug firms, found that patients fared worse on the drugs than had been expected, suggesting the medicines were not cost effective. Yet the panel decided to continue with the project.
The risk sharing scheme was set up by the government in 2002 to make disease-modifying multiple sclerosis drugs available on the NHS after the country’s health costs watchdog, the National Institute of Health and Clinical Excellence (NICE), ruled that they were not cost effective.
Under the terms of the scheme, the government agreed to pay for the drugs on the NHS while research was carried out to assess their long-term cost effectiveness. The agreement was that the NHS would then gradually stop paying for the drugs if patients did not appear to be benefiting.
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