About Careers MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

MS Drug from Sanofi Gets a No-No

by Dr. Enozia Vakil on December 30, 2013 at 5:39 PM
Font : A-A+

 MS Drug from Sanofi Gets a No-No

The US health authorities have rejected the Lemtrada drug aimed at helping those suffering from multiple sclerosis by Sanofi, which is already approved in Canada, Australia and the European Union.

The Food and Drug Administration (FDA) said Sanofi's subsidiary Genzyme, which makes the drug aimed at treating relapsing forms of the disease, had "not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects."

Advertisement

The FDA has also decided "one or more" clinical trials are necessary before approval of the drug -- a move Sanofi said would likely prevent the drug from being approved on the US market by March 31 next year, as originally planned.

"We are extremely disappointed with the outcome of the review and the implications for patients in the US suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease," Genzyme President David Meeker said in a statement.
Advertisement

"Genzyme strongly disagrees with the FDA's conclusions and plans to appeal the agency's decision," the statement added.

Lemtrada is one of the most promising drugs in Sanofi's pipeline, and was a key motivation behind the French firm's 2011 takeover of Genzyme for more than $20 billion.

The drug is already approved in the European Union, Canada and Australia.

Multiple sclerosis, a degenerative disease of the nervous system which disrupts the brain's ability to communicate with the body, affects some 2.1 million people in the world, including 410,000 in the United States.

According to Sanofi, the most common side effects of Lemtrada include infections of the upper respiratory tract and urinary tract and lymphopenia -- a reduction in the number of lymphocytes, a subset of white blood cells. Serious autoimmune conditions can also occur.

Source: AFP
Advertisement

Advertisement
Advertisement

Recommended Reading

Latest Drug News

 Parkinson's Unmet Needs Creates Path for New Entrants into the Market
Addressing the unmet needs of Parkinson's Disease by providing disease-modifying therapies could bring about a major shift in the way that patients are treated.
How Microrobots Could Help Treat Bladder Diseases?
Microrobots could swirl through a person's blood stream, search for targeted areas to treat for various ailments.
How Can Multivitamin Supplements Slow Cognitive Aging?
Supplementation with multivitamins is an inexpensive way for older adults to slow down memory loss.
 Ivosidenib Approved for Acute Myeloid Leukemia & Advanced Cholangiocarcinoma
Some people with an aggressive blood cancer called acute myeloid leukemia (AML) may soon have a new drug option called Ivosidenib that blocks the activity of IDH1 gene.
Sacubitril/valsartan Unleashes Hope for Heart Failure Patients
In case of cardiac failure where the ejection fraction is greater than 40%, sacubitril/valsartan can prove to be quite beneficial
View All
This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close
×

MS Drug from Sanofi Gets a No-No Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests