Keywords: Otsuka, EMEA, Abilify, Antidepresant, Schizophrenia

Otsuka withdraws EU its application for an extension of indication for Abilify

Article | 20 November 2009

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The European Medicines Agency(EMEA) has been formally notified by Otsuka Pharmaceutical Europe, a unit of the Japanese drugmaker, of its decision to withdraw its application for an extension of indication for the centrally authorized medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution.

Abilify was expected to be used in the treatment of major depressive episodes, as adjunctive therapy, in patients who have had an inadequate response to previous treatment with antidepressants.

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Abilify was first authorized in the European Union on June 4, 2004. It is currently indicated for the treatment of schizophrenia and for the treatment and prevention of manic episodes in bipolar I disorder. The application for the extension of indication for Abilify was submitted to the Agency on December 11, 2008.

The company stated in its official letter that the withdrawal was based on the EMEA’s advisory panel’s consideration that the long-term data provided in support of the proposed indication were insufficient, as long-term randomized controlled data are needed before this indication can be licensed. Abilify continues to be authorized for the currently approved indications.