FDA Greenlights First Bi-Monthly Injectable for Schizophrenia, Bipolar 1 Disorder
BIOMARKER
1. The FDA approved Otsuka and Lundbeck's extended-release injectable aripiprazole, Abilify Asimtufii, for schizophrenia treatment and bipolar I disorder maintenance therapy.
2. Abilify Asimtufii is the first long-acting injectable for these indications, requiring administration once every two months.
3. The new formulation is approved for use in adult patients.
4. The 031-201-00181 trial compared Abilify Asimtufii's efficacy with the once-monthly aripiprazole formulation, Abilify Maintena.
5. Pharmacokinetic analyses showed similar plasma aripiprazole concentrations for the once-every-two-month and once-monthly versions.
6. The 960-mg Abilify Asimtufii dose is generally well-tolerated and has a similar adverse event profile to Abilify Maintena.
7. Abilify Asimtufii comes in 960-mg and 720-mg prefilled syringes designed to deliver sustained plasma levels of aripiprazole.
8. The drug is administered via intramuscular injection to the gluteal muscle by a healthcare professional.
9. Abilify Asimtufii's label warns of an increased risk of death for elderly people with dementia-related psychosis treated with antipsychotic drugs.
10. Otsuka and Lundbeck will compete with Johnson & Johnson in the schizophrenia market, following J&J's FDA approval for Invega Hafyera in September 2021.