The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization of darvadstrocel (Alofisel, Tigenix SAU) for treatment-refractory complex perianal fistulas in patients with Crohn’s disease.
Darvadstrocel is a suspension of allogeneic expanded adipose-derived stem cells. It is the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe, the company notes in a press release.
“Perianal fistulas are estimated to affect up to 28% of patients in the first two decades after Crohn’s disease diagnosis and [darvadstrocel] offers new hope for those suffering from this severe and debilitating condition,” Julian Panés, MD, PhD, head of gastroenterology at the Hospital Clinic of Barcelona in Spain and president of the European Crohn’s and Colitis Organization, said in the release.
In clinical trials, darvadstrocel (formerly Cx601) “achieved higher combined remission and lower relapse rates than the current standard of care,” said Dr Panés.
The benefits of darvadstrocel were demonstrated in the phase 3 ADMIRE-CD trial, which involved 212 patients with Crohn’s disease and complex perianal fistulas whose condition did not respond to one or more therapies, including antibiotics, immunosuppressants, and tumor necrosis factor–alpha inhibitors.
After 24 weeks of treatment, about half of patients treated with darvadstrocel were in remission, compared to about a third of patients treated with placebo. With darvadstrocel, long-term remission of complex perianal fistulas was maintained in patients with Crohn’s disease for longer than 52 weeks, as reported by Medscape Medical News.
“Although there is a moderate difference between the treatment groups, the effect is considered to be clinically meaningful when other treatment options for fistulas have failed,” the EMA said in a statement.
The most commonly observed side effects include anal abscess and fistula, as well as procedural pain and proctalgia.
The positive CHMP opinion will now be sent to the European Commission. A decision is anticipated in the coming months, the company said.
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