Lemtrada(Sanofi/Genzyme) has Advisory Committee approval in US

In a surprise decision, an Advisory Panel to the FDA voted 14 to 0 that Lemtrada (alemutuzumab)from Sanofi/Genzyme should be approved to treat Multiple Sclerosis, despite its potential to cause cancer and other serious conditions. The panel's recommendation follows an initial report last week by reviewers for the FDA, who raised grave concerns about the drug's potential to cause an array of autoimmune conditions, in which the body mistakenly attacks its own cells, as well as its potential to cause thyroid, skin and breast cancer.Advisory panellists, considered that the risks could be worth it for some difficult-to-treat patients. The drug should be reserved for patients who have failed other therapies.

Lemtrada was EU approved in September 2013.