Europe gives green light to first long-acting injectable treatment for schizophrenia in adults
Janssen Pharmaceutical Companies de Johnson & Johnson has announced the approval by the European Commission (EC) of the long-acting atypical antipsychotic ‘Byannli’ (biannual paliperidone palmitate; PP6M) indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on paliperidone palmitate monthly (PP1M) or quarterly (PP3M) injectable formulations .
PP6M is the first approved biannual treatment for adults with schizophrenia with the longest dosing interval available for an antipsychotic drug in the European Economic Area, which could facilitate patient adherence, reports Europa Press.
“About 75 percent of people living with schizophrenia experience a relapse in symptoms, and this is often due to lack of adherence to prescribed medication,” said the Professor Eduard Parellada, director of the Schizophrenia Unit of the Institute of Neurosciences of the Hospital Clínic de Barcelona.
CE approval has been based on the “Study Route 6”, an international phase 3, randomized, double-blind, non-inferiority trial designed to demonstrate that PP6M is at least as effective as PP3M (quarterly injectable formulation) in preventing relapse in patients previously stabilized with a formulation of paliperidone palmitate shorter acting.
The study involved 702 adults with schizophrenia from 20 countries, including Spain, Bulgaria, France, Hungary, Italy, Poland, Russia, the Czech Republic and Turkey. The results showed the non-inferiority of PP6M compared to PP3M on the primary endpoint of time to first relapse at the end of the 12-month period.
No relapse for a year
The results showed that 92.5 percent of the patients who were treated with PP6M and 95.1 percent of those treated with PP3M remained relapse-free at 12 months. Relapse was defined as psychiatric hospitalization, increase in total score on the Positive and Negative Symptom Scale (PANSS), increase in individual PANSS item scores, violent behavior resulting in self-harm, or ideation. suicidal / homicidal.
“At Janssen we are committed to trying to reduce the devastating burden of mental illness. This approval by the European Commission is a key milestone in our long-standing work towards this goal, as it offers patients and their families the possibility of leading a life less conditioned by medication, ”said the Head of the Neuroscience Global Therapeutics Area, Janssen Research & Development, Dr. Bill Martin.
The EC approval follows the positive CHMP opinion last September for PP6M and the announcement of approval by the US Food and Drug Administration (FDA PP6M for the treatment of schizophrenia in adults after they have been adequately treated with PP1M for at least 4 months or PP3M for at least 3 months. The EC approval is valid in the 27 Member States of the European Union and in the countries of the European Economic Area (Norway, Iceland and Liechtenstein).