Otsuka Pharmaceutical has pulled an application in Europe to get an extension on the label for its big-selling antipsychotic Abilify, partnered elsewhere with Bristol-Myers Squibb.
The European Medicines Agency has been formally notified by the Japanese drugmaker of its decision to withdraw its application for an extension of indication for Abilify (aripiprazole), which 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. Otsuka’s European unit informed the EMEA that the withdrawal was based on concerns previously expressed by the agency’s Committee for Medicinal Products for Human Use.
Specifically, the CHMP had told Otsuka that the long-term data provided in support of the proposed indication were insufficient, “as long-term randomised controlled data are needed before this indication can be licensed”. More information about the withdrawal of Abilify will be made available “in due course”, the EMEA added.
Abilify was first authorised in the European Union in June 2004. It is currently indicated for schizophrenia and for the treatment and prevention of manic episodes in bipolar I disorder.
