Pharmaprojects R&D Pipeline News Feed
Invega gains US approval for the long-term maintenance of schizophrenia
2 May 2007
Johnson & Johnson (J&J) has gained further US approval for Invega (paliperidone ER), so that it is now indicated for both the short- and long-term treatment of schizophrenia. Initially approved as a short term schizophrenic treatment in Dec 2006, Invega is important to Johnson & Johnson, as its big-selling schizophrenia drug Risperdal is due to come off patent in December this year.
The approval followed positive interim efficacy data from a Phase III trial, in which 77.9% of patients in the treatment arm progressed without the recurrence of symptoms, compared to only 48.5% in the placebo group. The longer-term study also confirmed the drug's safety and tolerability profile, with treatment-emergent adverse events such as psychosis, insomnia and aggressive behaviour being more frequent in the placebo arm. In addition to clinical efficacy data, a positive view of the approval was given by George Simpson, Professor of Research at the Keck School of Medicine of the University of Southern California, who noted: “Physicians now have a once-daily treatment option that can help many patients reduce symptom severity and also help stabilize the patient with longer-term use”.
Invega will enter a market where competitors include Otsuka's aripiprazole, approved for long-term schizophrenia in 2003, and Lilly's olanzapine, which was launched in the US in 1996. However, with the latter being associated with weight gain, somnolence, speech disorders and rhinitis, it seems Invega’s excellent tolerability profile may offer a strong competitive advantage from the outset.
