December 30, 2013 The Food and Drug Administration (FDA) has rejected French drugmaker Sanofis multiple sclerosis (MS) treatment called Lemtrada, the company announced on Monday. The rejection is considered a serious blow to the company, which had the drug recently approved by other regulatory bodies. The FDA did not approve the drug on the grounds that the Sanofi-owned developer Genzyme had not demonstrated that its medical benefits offset its serious adverse effects, Sanofi said in a statement. FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada, the company added. Sanofi went on to say that it disagreed with the FDA ruling and planned to appeal it.The same drug was approved by EU regulators in September as well as by Canadian and Australian regulators more recently. Alemtuzumab, the active ingredient in the drug, targets a specific immune system protein and reorganizes immune system cells. The result is a significant suppression of inflammatory activity in patients with MS. Clinical trials showed that alemtuzumab was better than beta-interferons, a standard drug for relapsing-remitting MS. Some clinical evidence even found that it slowed the progression … Continue reading →

The FDA ruling could impact the value of Sanofi's Genzyme takeover, since the latter's shareholders had received so-called contingent value rights (CVRs) entitling them to future payments of up to $14 a share if certain goals were met. Sanofi said on Monday it did not expect to meet the CVR milestone of U.S. approval for Lemtrada by the end of March. Other milestones are related to the drug's sales and would likely be hard to reach without the U.S. market. Analysts on average had expected Lemtrada to generate annual sales of $707 million by 2018, according to forecasts compiled by Thomson Reuters. "Genzyme's takeover was about catching up in biologics, having a greater footprint in the United States, and also largely for Lemtrada,'' said Eric Le Berrigaud, analyst at Bryan Garnier & Co. "This is unquestionably a setback, as without a U.S. market such a product doesn't have the same potential.'' Costly Process The brokerage, which had forecast peak Lemtrada sales of $400 million in the United States, said it was scrapping the U.S. market from its forecasts. It argued it would take Sanofi at least three years to conduct the studies demanded by the FDA, and that, given an … Continue reading →

Denver, Colorado (PRWEB) December 29, 2013 SclerosisTreatment.com talks about this new method as one of the best natural treatments for MS at the moment. In its Multiple Sclerosis Natural Treatment review, the website reveals that patients dealing with this condition have so many disturbing symptoms that finding a quick and effective way to overcome the disease is a must. To find out more about this new natural treatment read the full review at: http://www.sclerosistreatment.com/2013/02/multiple-sclerosis-natural-treatment.html Symptoms of MS are going to vary depending on the location of the affected nerves. They can include dizziness, fatigue, weakness, numbness, tremor, but also vision problems, lack of coordination and slurred speech. For a complete list go to: http://www.mssociety.org.uk/what-is-ms/signs-and-symptoms One of the most important reasons why the Multiple Sclerosis Natural Treatment program is so appreciated is the fact that it targets the cause of MS to overcome it. When the cause is gone, symptoms will gradually disappear. Well, the creator of this new healing method claims that the real cause of MS is a damaged immune system. When the immune system is damaged, it attacks and destroys the sheaths that cover nerves, causing all the aforementioned symptoms. Dr. Gary M. Levin, the author of the … Continue reading →