Byannli(Paliperidone Janssen-Cilag International)

Byannli (Paliperidone Janssen-Cilag International) is recommended for marketing authorization as a maintenance treatment for schizophrenia in adult patients. It is indicated for patients stabilized with paliperidone or risperidone, and in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, it may be used without prior stabilization if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. The legal basis for this application is Article 10(c) of Directive 2001/83/EC, and the active substance is considered known. The marketing authorization opinion date was 30 April 2020.

In a multinational, randomized, double-blind, active-controlled, non-inferiority study comparing PP6M with PP3M, the relapse-free rate difference (PP6M vs PP3M) at Month 12 was -3.2%. The estimated relapse rate (Kaplan Meier model) for PP6M was 8.1%, compared to 5.2% for PP3M, resulting in a difference of 2.9%. The non-inferiority margin for relapse-free rates was -10%. Regarding safety, injection site pain TEAEs were reported in 4.0% of the PP3M active control group. TEAEs reported more frequently in the PP6M group (injection site related) were 12.3%, compared to 4.9% in the PP3M group. Specifically, injection site-related TEAEs for PP6M 700 mg eq. were 12.1%.