Regulatory Guidance

Sanofi MS drug under safety review in the EU for dangerous side effects

Apr 15, 2019

The European Medicines Agency is taking a closer look at safety issues linked to the use of a Sanofi multiple sclerosis drug, Lemtrada.

The review comes after fresh reports that the medication can trigger immune-mediated conditions, problems with heart and blood vessels and severe neutropenia (increased vulnerability to infection). 

In November, the FDA added a warning to the drug’s labeling about risks of rare but serious cases of stroke and tears in the linings of arteries associated with the use of Lemtrada. Similar side effects were reported by 13 patients between 2014, when the drug was approved, and 2018. 

Now, the EMA has stated that for the time being, Lemtrada should only be started in adults with relapsing-remitting MS that is highly active and that hasn’t improved with other disease-modifying therapies. The agency said it is also launching a safety analysis of all the potential risks associated with the drug to decide if further restrictions are warranted. 

As safety concerns for Lemtrada have risen, sales for the drug reportedly slumped about 15 percent between 2017 and 2018.