ABILIFY MAINTENA (aripiprazole) - Schizophrenia

The Committee deems that the clinical benefit of the proprietary medicinal products ABILIFY MAINTENA 720 mg and ABILIFY MAINTENA 960 mg (prolonged-release aripiprazole) prolonged-release suspension for injection in pre-filled syringe as a two-monthly injection is substantial in the MA indication.

Considering:

• pharmacokinetic data having reported similar mean plasma aripiprazole concentrations and areas under the time-concentration curve between prolonged-release aripiprazole 960 mg as a two-monthly injection after the 4th dose and prolonged-release aripiprazole 400 mg as a monthly injection after the 7th or 8th doses in a comparative study for which several limitations were identified (off-label clinical indication (bipolar disorder type I) in 30% of cases, prior aripiprazole treatment for only a third of patients, data only available for the 960 mg strength, high attrition rates, transposability),
• the absence of efficacy data versus an active comparator enabling to position the medicinal product in the care pathway, in a context in which the other prolonged-release therapeutic alternatives that can be administered in adults stabilized with aripiprazole (i.e., prolonged-release aripiprazole monthly injection or prolonged-release risperidone two-monthly injection) have demonstrated their non-inferiority versus an active comparator,
• the absence of data supporting an improvement in patient compliance, safety and/or quality of life compared to monthly injections, in particular,

but taking into account

• the known efficacy profile of aripiprazole as monthly injections currently available,
• the safety data having reported a similar safety profile between two-monthly injections and monthly injections, although with more injection site reactions (18.2% versus 9.0%, respectively) and weight gain (22.7% versus 20.9%, respectively),
• the benefit of having dosage forms enabling a different administration schedule, without, however, a formally demonstrated improvement in terms of quality of life or acceptability,

the Committee deems that the proprietary medicinal products ABILIFY MAINTENA 720 mg and ABILIFY MAINTENA 960 mg (prolonged-release aripiprazole) prolonged-release suspension for injection in pre-filled syringe as a two-monthly injection are range supplements that do not provide any clinical added value (CAV V) compared to the ABILIFY MAINTENA 300 mg and ABILIFY MAINTENA 400 mg (prolonged-release aripiprazole as a monthly injection) forms already listed.