US regulators have issued a green light for the first schizophrenia medicine dosed just four times a year, which could potentially help patients better stick to treatment and thus improve symptom control.
Following a priority review, the US Food and Drug Administration has approved Johnson & Johnson group Janssen’s atypical antipsychotic Invega Trinza - a three-month injectable formulation of paliperidone palmitate - for the treatment of the condition.
Clearance came on the back of data from a Phase III, long-term maintenance trial, published in by JAMA Psychiatry, in which 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. Clinical data also show that the drug’s safety profile is consistent with that of its once-monthly predecessor Invega Sustenna (paliperidone palmitate), approved by FDA back in 2009.
It is hoped that the new three-month version will go even further in boosting treatment adherence rates. As Janssen notes, patients with acute illness often do not have insight about their disease, which contributes their not taking medication or using treatment services, potentially leading to relapse.
“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,” commented trial investigator Joseph Kwentus, Precise Research Centers. “Recovery looks different for everyone, and the long-term symptom control offered by Invega Trinza can help patients work toward their own personal goals.”
Janssen said the drug should be available in the US mid-June.
Meanwhile, Janssen has entered an exclusive worldwide license and collaboration arrangement with Achillion Pharmaceuticals to develop and commercialise one or more of its lead hepatitis C virus (HCV) assets.
A key objective is to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen up for exploration will feature Achillion's ACH-3102, an NS5A inhibitor currently in Phase II clinical studies, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration, the firms noted.
Specific financial details were not disclosed, just that Achillion will be eligible for milestone payments based upon the achievement of specified development, regulatory and sales milestones and tiered royalties on future worldwide sales of any successful products.