Withdrawn application: Asimtufii, aripiprazole, Date of withdrawal: 02/05/2023, Initial authorisation
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 some concerns and its provisional opinion was that Asimtufii could not have been authorised for the maintenance treatment of schizophrenia.
The Agency noted that in the main study the company should have compared Asimtufii with the reference medicine (Abilify Maintena) available in the EU. As the company had not done so, the study presented by the company did not provide enough evidence to support the application.
Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Asimtufii did not outweigh its risks.
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