A web-blog (formerly known as Stu's Views and MS News), now published by MS Views and News, a patient advocacy organization. The information on this blog helps to Empower those affected by Multiple Sclerosis globally, with education, information, news and community resources.
~~ Scroll left side of this blog for needed resources. Also, use our 'search by topic' tool, to find specific information.
Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
Monday, November 11, 2013
Negative News from the FDA for a hopeful MS drug
Sanofi Multiple Sclerosis Drug May Have Too Many Risks (4) By Anna Edney and Simeon Bennett November 08, 2013
Sanofi’s multiple sclerosis treatment Lemtrada may not offer enough benefit to patients to outweigh risks including cancer, U.S. regulators said. Securities linked to the drug’s success plummeted.
Lemtrada’s “serious and potentially fatal safety issues,” which include the risk of autoimmune and thyroid diseases, may make the medicine too dangerous to approve unless there is substantial clinical benefit shown, Food and Drug Administration staff said in a report today. Agency reviewers also questioned whether Sanofi conducted adequate trials to prove the annual infusion works.
“That’s like a death sentence,” said Fabian Wenner, an analyst with Kepler Cheuvreux in Zurich, “It isn’t what everyone expected, an issue with the safety. It seems to be a more fundamental issue here.”