European Commission Gives Green Light to Alofisel

March 26, 2018

The European Commission approved Alofisel (darvadstrocel), a drug intended to treat complex perianal fistulas in adults with Crohn’s disease, based on the Committee for Medicinal Products for Human Use’s positive opinion in December.

The treatment for adult patients with nonactive to mildly active luminal Crohn’s disease is an allogeneic stem cell therapy that should be taken after conditioning of fistula.

The recommendations for approval stemmed from results of a Phase III ADMIRE-CD pivotal trial, which showed Alofisel’s effectiveness and ability to maintain long-term remission of treatment refractory complex perianal fistulas in patients over 52 weeks.

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