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FDA nod for Janssen schizophrenia treatment Invega Hafyera

September 3, 2021


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.

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