Firm says positive data from CARE-II means U.S. and EU filings for Lemtrada are on track for Q1 2012.
Sanofi’s Genzyme subsidiary says it is on track to file for U.S. and EU approval of the multiple sclerosis (MS) candidate Lemtrada™ (alemtuzumab) during the first quarter of 2012, on the back of positive data from a second Phase III study.
The ongoing, 840-patient CARE-MS II study compared treatment of relapsing remitting MS (RRMS) using either Lemtrada or Rebif™ over two years. The trial met both its primary endpoints and demonstrated that Lemtrada therapy led to a 49% reduction in relapse rate above that resulting from Rebif therapy, and a 42% reduction in the risk of sustained accumulation of disability, as measured by the Expanded Disability Status Scale (EDSS) over two years of study.
Participants receiving Lemtrada were given the humanized anti-CD52-targeting mAb intravenously every day for five days, and then received another three days of intravenous therapy a year later. Patients in the Rebif treatment arm received the interferon beta-1a by injection three times a week throughout the two years of study.
The CARE-II results come less than a month after Genzyme announced positive data from the CARE-I Phase III trial, which showed that 78% of patients treated using alemtuzumab remained relapse-free for two years, whereas 59% of Rebif-treated patient remained relapse-free at two years.