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 Ongentys could not have been authorised for the treatment of signs and symptoms of early stage Parkinson’s disease.

The Agency noted that the data on the effectiveness of Ongentys were not robust enough and indicated only a small effect of the medicine on MDS-UPDRS score and other measures of effectiveness. It was therefore not clear whether patients with mild symptoms of early stage Parkinson’s disease would benefit from treatment with Ongentys.

Therefore, at the time of the withdrawal, the Agency’s opinion was that, because effectiveness was not proven in the broader use, the benefits of Ongentys did not outweigh its risks.