J&J’s Invega to launch in January
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Johnson & Johnson's antipsychotic Invega (paliperidone extended-release) received FDA approval Dec. 19, and the firm is set to launch the schizophrenia treatment in early January. The follow-on to Risperdal (risperidone) is the first new atypical antipsychotic approved by FDA for schizophrenia since 2003. Approval was based on three six-week, placebo-controlled trials in more than 1,600 patients worldwide. J&J is also conducting two Phase III head-to-head trials of Invega compared to AstraZeneca's Seroquel (quetiapine) in both schizophrenia and bipolar disorder; results are expected in 2007. Invega delivers paliperidone through the Alza OROS extended-release technology, which results in minimal fluctuations in blood level, according to J&J...