NICE's Unrestricted MS Indication For Lemtrada Could Boost It Ahead Of Rivals
This article was originally published in The Pink Sheet Daily
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.
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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.
Genzyme had a mixed few days with its MS drugs at NICE, with Aubagio finally succeeding but Lemtrada struggling on the back of a tough benefit/risk profile.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.