MS Coalition Submits Letter to FDA Regarding Lemtrada™ Denial
February 14, 2014
The Multiple Sclerosis Coalition (MSC) is a collaborative network of independent MS organizations whose mission is to increase opportunities for cooperation and provide greater opportunity to leverage the effective use of resources for the benefit of the MS community. Members of this organization have collectively sent a letter to the United States Food and Drug Administration (FDA), asking for clarification and reconsideration of various issues involved in the FDA’s recent denial of Lemtrada™ (alemtuzumab, formerly Campath).
In late December 2013, members of the MS community learned that Lemtrada did not receive approval from the United States Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis (MS). Genzyme, a Sanofi company, announced that it had received a Complete Response Letter from the FDA, informing them that the application for their drug is "not ready for approval." Genzyme plans to appeal the decision. For more information, please see MSAA’s article, "Lemtrada Denied FDA Approval; More Studies Needed."
The decision to not approve the drug came as unexpected news to many in the MS community – including medical professionals and MS organizations – especially since the month before, an FDA advisory committee recommended to approve the drug. The problem cited by the FDA was in the study’s design, where due to dramatic differences in administration and side effects between the study’s treatment arms, blinding both the participants and the treating physicians was not possible. With encouraging study results and approvals in several other countries (including Canada, Mexico, Australia, and those of the European Union), advocates for the MS community are expressing their concern over this decision.
In the MSC’s letter to the FDA, member organizations of the MSC state that they support the availability of more treatment options for the MS population. Additionally, the MSC is concerned over individuals who may travel to other countries for treatment, referred to as “Medical Tourism.” By doing so, individuals would not receive the necessary Risk Evaluation and Mitigation Strategy (REMS) for early recognition and treatment of potential adverse events, putting themselves at risk for serious health issues. Another point discussed in the letter asks the FDA about a shift by the agency regarding the validity of the Expanded Disability Status Scale (EDSS) as an outcome measure in MS clinical trials, which despite limitations, has played a central role in MS therapy development.
|Last Updated on Tuesday, 18 February 2014 08:26|