<p>On 13 December 2024, the European Commission withdrew the marketing authorisation for Alofisel (darvadstrocel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharma A/S, which notified the European Commission of its decision to permanently stop the marketing of the product in the EU.</p><p>Alofisel was granted marketing authorisation in the EU on 23 March 2018 for the treatment of complex perianal fistulas. The European Public Assessment Report (EPAR) for Alofisel is updated to indicate that the marketing authorisation is no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.</p> </div>
Therapeutic Area (MeSH)
ATC Code
L04
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| darvadstrocel | N/A | darvadstrocel |
EMA Name
Alofisel
Medicine Name
Alofisel
Aliases
N/ANo risk management plan link.
