Based on the review of the information and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns, and its provisional opinion was that Orencia could not have been authorised for the prevention of acute graft-versus-host-disease.

The main study did not show that Orencia prevented severe, acute graft-versus host disease. Although there appeared to be an initial benefit, this decreased over time. Furthermore, there were uncertainties about whether Orencia may have a negative effect on the risk of chronic (long-term) graft-versus-host disease compared with placebo. In addition, there were uncertainties regarding the long-term effectiveness of Orencia in preventing graft-versus-host disease due to the limited follow-up of patients in the main study (i.e. after 180 days).

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Orencia in the prevention of acute graft-versus-host-disease did not outweigh its risks.