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Lundbeck submitts New Drug Application to FDA


H Lundbeck and Otsuka Pharmaceutical Co have announced that the US Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena for the maintenance treatment of Bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 28 July 2017, to complete its review.

Abilify Maintena

Abilify Maintena is an extended-release injectable suspension, for intramuscular use developed by Otsuka in Japan and is co-commercialized by the alliance between Otsuka and Lundbeck. Abilify Maintena was approved in the U.S. in 2013 for the treatment of adults with schizophrenia and is available in a number of countries including the U.S. Europe, Canada and Australia. Efficacy and safety for Abilify Maintena is supported by a short-term (12-week), randomized, double-blind, placebo-controlled trial in acutely relapsed adults, as well as a longer term (52-week) placebo-controlled, double-blind, randomized-withdrawal study for the maintenance treatment of schizophrenia.

Abilify Maintena, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. After an initial injection of Abilify Maintena along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time. It provides a treatment option to address two of the most important considerations in the management of schizophrenia — improving symptoms in patients with an acute relapse of their disease and reducing the risk of relapse or the re-emergence of worsening of symptoms. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for an extended period of time[iii].