Biogen Seeks Tysabri Magic TOUCH Again: REMS Allows Rapid PML Response
Biogen Idec developed TOUCH, the restricted distribution risk management plan for its monoclonal antibody Tysabri (natalizumab), to save that product from market withdrawal in 2005-2006
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The specter of Tysabri and its restrictive REMS loomed over the review of Takeda’s Entyvio, making for an unusually high level of communication and discussion from Phase II until late in the review cycle – a tally that includes 14 pre-BLA face-to-face meetings between FDA and the sponsor, as well as two advisory committee reviews and two turns before FDA’s REMS Oversight Committee.
A three-month EMEA safety review confirms that two years of treatment with the monoclonal antibody increases the risk for PML.
But economy and competitive MS market could provide headwinds going forward.