Otsuka Pharmaceutical Co., Ltd.

March 30, 2015

Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of Schizophrenia, Received Positive CHMP Opinion (Approval in EU)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) on 26th March issued a positive opinion (approval in EU) for the new pre-filled dual chamber syringe kit to administer Abilify Maintena® for the maintenance treatment of schizophrenia.

The dual chamber pre-filled syringe is a new addition to the Abilify Maintena offering. Reconstitution occurs within the pre-filled dual chamber syringe, in a single step, which allows for easier handling. This product enhancement offers another option to simplify delivery of care to patients with schizophrenia and provides healthcare professionals with an easier-to-use option.

CHMP positive opinion (approval in EU) of the dual chamber kit follows the recent approval of the deltoid muscle as a new injection site for Abilify Maintena, the latter approval providing patients with a wider range of treatment options.

These new additions to Abilify Maintena are expected to be available for use later in the year.