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.