FDA Accepts Genzyme's Resubmission For Lemtrada In MS

Genzyme, a Sanofi company, announced in a press release that the Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) resubmission for Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis (MS). The FDA will take action on the application within six months, in the fourth quarter of 2014. The FDA had denied the application, citing issues with clinical trials in its Complete Response Letter (CRL) in December of 2013.

In March, the physicians who took part in the Lemtrada studies wrote a letter to The Lancet to “urge the FDA to re-evaluate and revoke this decision.” Genzyme was also unhappy with the denial, but now says, “The Company resubmitted the sBLA earlier this month following constructive discussions with the agency.”

Lemtrada 

Lemtrada (alemtuzumab) binds to white blood cells, stopping them from attacking myelin in the brain. Stopping these immune cell attacks helps slow the progression of MS. Lemtrada is taken intravenously to prevent mild, moderate, or severe myelin degradation and resulting nerve pathway disruptions that cause motor and cognitive disabilities. The physicians who participated in the clinical trials since 1991 expressed confidence in the results, noting that Lemtrada studies have been published in major journals. The physicians stated that Lemtrada is approved in other countries using the same studies. They also said that other drugs have been approved in trials without a placebo, especially MS drugs.

Just last week, the National Institute for Health and Care Excellence (NICE) issued its final guidance, which recommended that Lemtrada be reimbursed on the NHS for relapsing remitting multiple sclerosis (RRMS).

Complete Response Letter

The FDA’s CRL in December of 2013 informed Genzyme that its clinical trials were insufficient. The federal agency, which said that trials were not well controlled and were inadequate, requested additional trials with different designs. After discussions with the FDA, Genzyme resubmitted the same data from the clinical studies in the original submission. Additionally, it provided supplemental information and analysis that specifically addressed the FDA’s concerns.

Lemtrada Marketing

Genzyme stands behind its drug and its clinical trials. Genzyme President and CEO, David Meeker, M.D. said, “We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile.”

Genzyme has developed and submitted Lemtrada for regulatory approval worldwide. It holds worldwide rights to alemtuzumab, however Bayer HealthCare will co-promote alemtuzumab in MS in the United States upon its approval. Bayer will receive payments based on sales revenue.