Janssen seeks EU approval for twice-yearly schizophrenia treatment

Janssen has submitted a marketing authorisation extension application to the European Medicines Agency (EMA) for paliperidone palmitate six-monthly (PP6M) as a maintenance treatment for adults living with schizophrenia.

In particular, Janssen is seeking approval for the twice-yearly regimen in adult patients with schizophrenia who are already clinically stable on paliperidone palmitate one‑monthly (PP1M) or three-monthly (PP3M) injectable products.

The application for the extended approval is based on Janssen’s Route 6 study, which evaluated PP6M in 702 adults living with schizophrenia across 20 countries, including Bulgaria, Czech Republic, France, Hungary, Italy, Poland and Spain.

The data demonstrated non-inferior efficacy of the PP6M regimen compared to PP3M on the primary endpoint of time to relapse at the end of the 12-month period, in both the intent-to-treat and per-protocol analysis sets.

“Antipsychotic medication plays an important role in schizophrenia symptom control; however, non-adherence to prescribed medicines has been recognised as a problem worldwide,” said Mathai Mammen, global head of Janssen Research & Development, Johnson & Johnson.

“Addressing this challenging aspect of treatment has been the catalyst for our research and development of long-acting injectable medications for people living with schizophrenia,” he added.

Schizophrenia is thought to impact approximately 20 million people worldwide and an estimated 3.7 million people in the EU.

It is characterised by distortions in thinking, perception, emotions, language, sense of self and behaviour, resulting in neurological impairment, severe disability and increased mortality.