Lemtrada alemtuzumab regulatory update

Sanofi's Genzyme Corp. unit said FDA accepted for review a resubmitted sBLA for Lemtrada alemtuzumab to treat relapsing multiple sclerosis (MS). Genzyme said it expects a decision in 4Q14; the specific PDUFA date is not disclosed. According to the company, FDA said at least 1 additional comparator trial with a "different design and execution" would be needed for Lemtrada's approval (see BioCentury, Jan. 6 & April 14). Genzyme said the resubmitted sBLA includes the same studies as the original sBLA along with "supplemental analyses and additional information" to address FDA's issues, but declined to disclose details. The product has Fast Track designation in the U.S.

Separately, The U.K.'s NICE issued final guidance recommending Lemtrada to treat relapsing-remitting MS (RRMS). The final guidance is in line with an April final appraisal determination (FAD) (see BioCentury, April 7). The humanized mAb against CD52 is approved in Brazil, Mexico, Canada, Australia and the EU. Bayer AG (Xetra:BAYN, Leverkusen, Germany) has an option to co-promote alemtuzumab for MS and full rights in solid organ transplant indications. The product is partnered with BTG, which owns the IP and is eligible for undisclosed royalties in all approved indications (see BioCentury, April 6, 2009 & June 8, 2009). ...