ARTICLE | Clinical News

Lemtrada alemtuzumab regulatory update

January 6, 2014 8:00 AM UTC

On Dec. 30, 2013, FDA issued a complete response letter for an sBLA from Sanofi's Genzyme Corp. unit for Lemtrada alemtuzumab to treat relapsing multiple sclerosis (MS). According to the company, FDA said Genzyme did not submit data from adequate and well-controlled trials that show the "benefits of Lemtrada outweigh its serious adverse effects." The agency said >=1 additional active-comparator trial with a "different design and execution" is needed for Lemtrada's approval. Sanofi said it plans to appeal the complete response.

In November, FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted in favor of Lemtrada despite concerns raised by FDA reviewers, who said the open-label design of the pivotal trials for Lemtrada - the Phase II CAMMS223 trial and Phase III CARE-MS I and CARE-MS II trials - raises "uncertainty" about the data. The reviewers also had questioned the "serious and potentially fatal safety issues" with Lemtrada, highlighting the incidence of autoimmune diseases, including idiopathic thrombocytopenia purpura (ITP), and malignancies, including thyroid cancer and melanoma, in MS patients (see BioCentury, Nov. 18, 2013). The humanized mAb against CD52 is approved for MS in the EU, Canada and Australia (see BioCentury, Sept. 23, 2013). Sanofi said it has launched Lemtrada in Germany, Finland, Sweden, Norway, Austria and Denmark and expects to launch it in additional markets in Europe and North and South America this year. ...