Based on the review of the data and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had concerns and its provisional opinion was that Kinharto could not be authorised for the treatment of chronic (long-term) heart failure.

Although the results from the main study showed that treatment with Kinharto increased the time until patients experienced worsening of their heart failure or died, the Agency considered that this main beneficial effect was modest and could not be supported by other results from the study. In addition, although the data appeared to suggest that patients with a more severely reduced ejection fraction (below 30%) would be more likely to benefit from Kinharto, there was not enough evidence to support limiting treatment to this subgroup, nor could other studies be found to back up this subgroup finding. Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Kinharto did not outweigh its risks.