Seven therapies have been put forward for approval in the European Union, bringing closer new options for a range of conditions including Crohn’s disease, diabetes and cancer.
Included in the latest pack of Committee for Medicinal Products for Human Use (CHMP) recommendations is Tigenix’ Alofisel (darvadstrocel), a new advanced therapy medicinal product (ATMP) for the treatment of complex perianal fistulas in patients with Crohn’s disease.
Perianal fistulas, a common complication of Crohn’s disease, occur when an abnormal passageway develops between the rectum and the outside of the body, potentially leading to incontinence and sepsis. Complex fistulas, which are rare, are more treatment resistant than simple fistulas.
Alofisel contains expanded adipose stem cells that interrupt proliferation of lymphocytes and reduce the release of pro-inflammatory cytokines at inflammation sites, which lessens inflammation and potentially allows the tissues around the fistula tract to heal.
In clinical trials, after 24 weeks of treatment half of patients treated with Alofisel were found to be in remission, compared to a third of the patients given aplacebo.
Read more: http://bit.ly/EUTherapiesApproval