Cell & Gene Therapies in Dermatology Disorders: Therapeutic Analysis

Currently, there are only two cell and gene therapies (CGTs) on the market across all gastroenterology (GI) indications. Anterogen’s Cupistem, indicated for the treatment of anal fistula in adult patients, was the first adipose tissue-derived mesenchymal stem cell (ASC) asset to receive approval in the GI market in Japan, 2012. This was followed by Takeda Pharmaceutical’s Alofisel (darvadstrocel), which received approval from the European Medicines Agency (EMA) in 2018 and from Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) in 2021. However, on December 13th, 2024, the EMA announced the withdrawal of Alofisel (darvadstrocel) from the EU market citing lack of data that demonstrated the benefit of this therapy in Crohn’s fistulas.
Both marketed therapies are prescribed when a patient has shown an inadequate response to at least one conventional or biologic therapy.

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