Otsuka and Lundbeck’s Abilify Asimtufii (aripiprazole) Receive the US FDA’s Approval as First Long-Acting Injectable for Schizophrenia or Bipolar I Disorder
Shots:
- The US FDA has approved the NDA for Abilify Asimtufii (IM, q2mos.) extended-release injectable suspension for schizophrenia or maintenance monotx. treatment of bipolar I disorder in adults
- The approval was based on the results from a 32wk. PK bridging analysis evaluating Abilify Asimtufii in 266 patients with schizophrenia & bipolar I disorder across multiple care centers while investigators assessed 960 & 720mg doses across trial participants
- Both doses met 1EPs & demonstrating similar aripiprazole plasma concentrations and comparable efficacy to Abilify Maintena (400mg, qm) treatment dose. Additionally, the product is available in 720mg/2.4mL and 960mg/3.2mL dosage strengths
Ref: Otsuka | Image: Otsuka
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
