Takeda's (TYO: 4502) first-in-class allogneic stem cell therapy for the treatment of perianal fistulas in patients suffering from Crohn's Disease has been snubbed in a recommendation of the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales.
Alofisel (darvadstrocel) treats perianal fistulas, a common complication in Crohn's Disease patients that can lead to pain and bleeding and may significantly degrade a patient's quality of life.
Despite Alofisel's status as a first-of-its-kind therapy with strong clinical trial results under its belt — previous research indicated patients taking the drug were 44% more likely to enter remission than those on placebo, with followup analyses confirming long-term efficacy and safety — NICE remained unimpressed, citing the relatively small growth in patients experiencing total remission compared to placebo.
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