Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials
This article was originally published in The Pink Sheet Daily
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.
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Though not totally convinced about long-term effectiveness and patient adherence, NICE's decision not to restrict Lemtrada's indication could place it ahead of Gilenya and Tysabri for relapsing-remitting multiple sclerosis.