Genzyme Nabs Elusive Lemtrada Approval, But As Third-Line MS Therapy
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA says therapy for relapsing multiple sclerosis should be reserved for patients who fail two or more other MS treatments; REMS includes four-year follow up.
You may also be interested in...
ECTRIMS 2016: Alemtuzumab Benefits Continue Six Years Post-Treatment
The continuing benefits of Sanofi’s multiple sclerosis therapy Lemtrada six years after two short courses bolster the case for its use early in the course of the disease.
Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials
Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.
Sanofi/Genzyme Primed Patient Community For Campath’s Removal From Commercial Distribution
As Sanofi/Genzyme plans to take leukemia drug Campath out of the commercial market in the U.S. and Europe so it will not undercut sales of the same compound in a different indication, patient advocates are confident that a patient-access system will continue providing the drug to those who need it.