Genzyme resubmits MS drug for FDA approval

Cambridge biotech Genzyme said Friday that it has resubmitted its application for a cdrug called Lemtrada that was rejected by the Food and Drug Administration in December.

In a press release, Genzyme said it had resubmitted the application “earlier this month following constructive discussions with the agency.”


Genzyme said a six-month review period has been assigned for Lemtrada and added that it expects the FDA to take action on the resubmitted application in the fourth quarter.

The potential for Lemtrada was among the reasons why French drug maker Sanofi SA acquired Genzyme in 2011 for $20.1 billion. As part of that deal, Sanofi agreed to reward former Genzyme stockholders if the drug achieved certain milestones in the US market regarding approval and sales.

Get Talking Points in your inbox:
An afternoon recap of the day’s most important business news, delivered weekdays.
Thank you for signing up! Sign up for more newsletters here

But even though the drug has now been approved by regulators in the European Union, Australia, Brazil, Canada, Mexico, and Guatemala, the FDA questioned the integrity of Lemtrada’s clinical trials and cited the risk of potentially serious side effects in its December rejection.

At that time, a Genzyme executive indicated that the company might appeal the FDA ruling. But in April, the company said it would file an updated application that would specifically address issues raised by the FDA.

In its Friday release, Genzyme said it submitted an updated application earlier this month.


Genzyme scientists spent more than a decade developing Lemtrada for the treatment of multiple sclerosis, a disease that affects the central nervous system. About 1,700 patients were involved in clinical testing of the drug. More than 2.3 million people have been diagnosed with MS worldwide, including about 400,000 in the United States.

Chris Reidy can be reached at
Loading comments...
Real journalists. Real journalism. Subscribe to The Boston Globe today.
You're reading  1 of 5 free articles.
Get UNLIMITED access for only 99¢ per week Subscribe Now >
You're reading1 of 5 free articles.Keep scrolling to see more articles recomended for you Subscribe now
We hope you've enjoyed your 5 free articles.
Continue reading by subscribing to for just 99¢.
 Already a member? Log in Home
Subscriber Log In

We hope you've enjoyed your 5 free articles'

Stay informed with unlimited access to Boston’s trusted news source.

  • High-quality journalism from the region’s largest newsroom
  • Convenient access across all of your devices
  • Today’s Headlines daily newsletter
  • Subscriber-only access to exclusive offers, events, contests, eBooks, and more
  • Less than 25¢ a week
Marketing image of
Marketing image of