Sanofi (Genzyme) Plans To Appeal FDA Decision to Not Approve Lemtrada For Treatment of Multiple-Sclerosis
Posted Dec 31 2013 1:11pm
Back in 2012 the FDA did approve another drug from Genzyme, who is owned by Sanofi for the treatment of multiple-sclerosis and the current drug they are seeing approval for has been approved in Europe, Canada and Australia. The Genzyme division of Sanofi produced the drug, Aubagio, which is a pill.
Lemtrada is an injectable drip drug and the company argues it would take 3 years to produce the trials that the FDA is requesting. It would seem to me that the pill would be a preferable treatment but again I’m no expert on MS drugs by any means. BD
Pharmaceutical company Sanofi, which owns Genzyme, will appeal a U.S. Federal Drug Administration (FDA) decision not to approve its multiple-sclerosis treatment Lemtrada at this time, according to a press release today, Dec. 30.
The FDA in a letter to Genzyme said its drug Lemtrada application can't immediately be approved because Genzyme hasn't submitted evidence showing its benefits outweigh its side effects.
Lemtrada already has European Union, Canadian and Australian approval and is under review in other countries.
U.S. Food and Drug Administration staff said Lemtrada increased the risk of autoimmune and thyroid diseases, including diabetes and cancer.
Sanofi is the parent company of Genzyme, which has offices in Cambridge and Framingham. French drug maker Sanofi purchased Genzyme for $20.1 billion in 2011 based largely on anticipated sales of Lemtrada.