A recent study's findings indicate that Alofisel, a medication used to treat complex anal fistulas in adults with Crohn's disease, is ineffective. Based on the information at hand, the hazards of using Alofisel would not be outweighed by the benefit, which is no longer proven.
When Alofisel was first authorised in 2018, its benefit was considered modest and the company was asked to provide the final results of another, larger study (ADMIRE-CD II). This study, which was assessed by the CAT (EMA’s committee for advanced therapies), failed to demonstrate that Alofisel is more effective than placebo (a dummy treatment) at treating complex anal fistulas in adults with Crohn’s disease. The safety profile of Alofisel in the ADMIRE-CD II study was consistent with previous studies; the CAT noted that there are risks associated with the medicine, however no new safety signals were identified in the latest study. Data from other supportive studies were also submitted by the company. The available data were considered insufficient to confirm the benefits of Alofisel. As the company that markets Alofisel considered that it was not possible for them to provide additional data on the effectiveness of the medicine as expected by EMA, it has decided to withdraw the medicine from the European Union (EU) market.
A direct healthcare professional communication (DHPC) will be sent shortly to healthcare professionals prescribing, dispensing or administering the medicine. The DHPC will also be published on a dedicated page on the EMA website.
Data from study ADMIRE-CD II were assessed in the context of an application for a type II variation to the marketing authorisation of Alofisel, submitted to comply with an obligation to provide the final results of the study by mid-2024. The assessment was carried out by EMA’s Committee for Advanced Therapies (CAT), responsible for questions concerning advanced therapy medicinal products (ATMPs) for human use. The application was withdrawn after the CAT had evaluated the information provided by the company and had prepared questions for the company. After the Committee had assessed the company’s responses to the questions, there were still some unresolved issues. As the company considered that it was not possible for them to provide additional data on the effectiveness of Alofisel as expected by EMA, they withdrew their application for the type II variation. The company subsequently communicated to the European Commission their intention to withdraw the marketing authorisation for Alofisel in the EU.
Once the European Commission has issued its final decision on the withdrawal of the marketing authorisation, Alofisel will no longer be authorised in the EU.
Learn more: Alofisel withdrawn from the EU market | European Medicines Agency (EMA)
