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FDA nod for Janssen schizophrenia treatment Invega Hafyera

The phase 3 study results showed that 92% of patients were relapse-free after 12 months


The US Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate) for the treatment of schizophrenia in adults.

The FDA approval of the Janssen drug is based on phase 3 study results, which showed the non-inferiority of Invega Hafyera compared to Invega Trinza. Results found that 92.5%% of patients treated with Invega Hafyera and 95% treated with Invega Trinza were relapse-free at 12 months.

Invega Hafyera is a twice-yearly injectable and therefore offers patients fewer doses per year than other schizophrenia medicines.

The long-acting regime joins Janssen’s existing one-month and three-month formulations, Invega Sustenna and Invega Trinza, and a two-week injection known as Risperdal Consta.

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva, medical director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator. “The phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”

Last year, the National Council for Mental Wellbeing and the American Psychiatric Association expanded their advice on the recommended use of long-acting injectables for appropriate adult patients living with schizophrenia.

“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” said Bill Martin, global therapeutic area head, neuroscience, Janssen Research & Development. “[This] approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”

Article by
Bryony Andrews

3rd September 2021

From: Regulatory



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