FDAnews Drug Daily Bulletin

Genzyme Receives Refuse-to-File Letter on MS Indication for Lemtrada

Sept. 10, 2012
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The FDA has issued Genzyme a refuse-to-file letter on its sBLA for Lemtrada as a treatment for relapsing multiple sclerosis (MS). The agency wants the Sanofi subsidiary to revise data sets in the application, but no additional clinical trial data was requested, the company said. Genzyme will work with the FDA over the coming weeks to revise the application and resubmit it as soon as possible.
Washington Drug Letter