No to Lemtrada. The FDA listens to their medical advisory panel and rejects Lemtrada--citing serious infections, malignancies and other autoimmune diseases in patients taking Lemtrada. They also remark that the clinical trials were "fatally flawed"--since they were open label and not blinded.


FDA spurns Sanofi's Lemtrada on fatally flawed PhIII design
www.fiercebiotech.com
Sanofi has been slammed against the regulatory wall at the FDA, picking up a stinging rejection of its multiple sclerosis drug Lemtrada with orders to go back to the clinic for a major round of new...