The FDA has approved Johnson & Johnson’s Invega Trinza (three-month paliperidone palmitate) for schizophrenia.
Invega Trinza had been under priority review from the US regulator and J&J‘s Janssen business aims to launch the long-lasting atypical antipsychotic injection by mid-June.
Before patients can be started on the drug they must first be taking Janssen’s Invega Sustenna, a one-month form of paliperidone palmitate, and have their symptoms adequately controlled for at least four months.
Invega Sustenna, which is marketed as Xeplion in Europe, saw its 2014 sales grow by 27% to $1.6bn and J&J will be hopig Invega Trinza will further grow its Invega franchise.
Husseini Manjo, global head of the neuroscience therapeutic area of Janssen research and development, said: “Building on Janssen’s more than 50 years of leadership in developing innovative mental health therapies and helpful programmes, this medication offers a new paradigm for treating people living with schizophrenia.”
Phase III trials, published in JAMA Psychiatry, showed 93% of patients treated with the drug did not experience a significant return of schizophrenic symptoms.
Trial investigator Joseph Kwentus, from Precise Research Centers, said: “With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control.
“Recovery looks different for everyone and the long-term symptom control offered by Invega Trinza can help patients work toward their own personal goals.”