US health watchdog rejects Sanofi's MS drug

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.

add to favorites email to friend print save as pdf

Related Stories

Sanofi-Aventis to buy Genzyme for $20.1 bln cash

Feb 16, 2011

(AP) -- French drug maker Sanofi-Aventis SA has agreed to buy Genzyme Corp. in a sweetened all-cash $20.1 billion deal that ends months of corporate haggling and positions Sanofi at the forefront of the market ...

Sanofi-Aventis says gets US approval for Genzyme bid

Oct 20, 2010

French pharmaceutical giant Sanofi-Aventis said on Wednesday that US competition authorities had not raised any objections to its hostile bid for US biotechnology group and rare disease specialist Genzyme.

Aubagio approved for multiple sclerosis

Sep 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

Mar 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.

Genzyme board rejects Sanofi bid

Aug 30, 2010

The board of directors at US biotechnology firm Genzyme has unanimously rejected an 18.5-billion-dollar takeover offer from French pharmaceutical giant Sanofi-Aventis, Genzyme said Monday. ...

Recommended for you

No added benefit proven for umeclidinium/vilanterol in COPD

4 hours ago

The drug combination umeclidinium/vilanterol (trade name Anoro) has been approved since May 2014 for adults with chronic obstructive pulmonary disease (COPD). In an early benefit assessment pursuant to the Act on the Reform ...

Ebola vaccine not before late 2016: GSK researcher

Oct 17, 2014

An Ebola vaccine by British pharmaceuticals giant GlaxoSmithKline may not be ready for commercial use until late 2016 and should therefore not be seen as the "primary answer" to the current outbreak, a company researcher ...

Chimerix gets FDA OK to test drug for Ebola

Oct 17, 2014

(AP)—A North Carolina drugmaker plans to test its experimental antiviral drug in patients who have Ebola, after getting authorization from regulators at the Food and Drug Administration.

Esbriet, ofev approved to treat deadly lung disease

Oct 16, 2014

(HealthDay)—Two new drugs have been approved by the U.S. Food and Drug Administration to treat progressive lung scarring from an uncertain cause, medically called idiopathic pulmonary fibrosis (IPF).

FDA weighs removing bolded warning from Chantix

Oct 14, 2014

(AP)—The Food and Drug Administration will ask a panel of experts later this week whether a bold-letter warning on the anti-smoking drug Chantix should be removed based on company-supported evidence that the drug does not ...

User comments