US health watchdog rejects Sanofi's MS drug

December 30, 2013

French drug giant Sanofi announced Monday US health authorities had rejected its Lemtrada drug for some forms of multiple sclerosis, which is already approved in the European Union, Canada and Australia.

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."

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 who remain in need of alternative therapies to manage a devastating disease," Genzyme President David Meeker said in a statement.

"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 and urinary tract and lymphopenia—a reduction in the number of lymphocytes, a subset of . Serious autoimmune conditions can also occur.

Explore further: Aubagio approved for multiple sclerosis

Related Stories

Aubagio approved for multiple sclerosis

September 13, 2012
(HealthDay)—Aubagio (teriflunomide) has been approved by the U.S. Food and Drug Administration to treat adults with relapsing forms of multiple sclerosis (MS).

US approves new multiple sclerosis capsules

March 27, 2013
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults with hard-to-treat forms of the disease.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.