EMA receives filing for Janssen’s twice-yearly schizophrenia jab

pharmafile | December 7, 2020 | News story | Sales and Marketing EMA, Janssen, schizophrenia 

The European Medicines Agency (EMA) has received Janssen’s Marketing Authorisation Extension for paliperidone palmitate six-monthly (PP6M), an injectable therapy administered just twice a year, as a maintenance treatment of schizophrenia in adult patients.

In support of the application, Janssen has submitted data generated from a study of PP6M in 702 schizophrenia patients across 20 countries. The data showed that 81.3% of patients receiving PP6M did not relapse for 12 months, while the therapy proved non-inferior to PP3M in reducing time until relapse at the end of the 12-month period.

“We designed this unique dosing regimen so people with schizophrenia and their healthcare team can focus less on medication intervals and more on other aspects of their treatment plan, such as psychosocial interventions,” commented Bill Martin, Global Therapeutic Area Head, Neuroscience at Janssen Research & Development. “We look forward to working with the European Medicines Agency to add a six-month formulation to our family of paliperidone palmitate products.”

If the Agency were to give its approval to Janssen to market the formulation, PP6M would represent the longest dosing interval available in an antipsychotic therapy within the European Economic Area.  

However, the therapy is only intended for use in patients who have seen their condition stabilise through the use of a shorter acting formulation of paliperidone palmitate.

Matt Fellows

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