The FDA approved Invega (paliperidone), a once-daily extended-release version of Johnson & Johnson’s blockbuster schizophrenia drug, Risperdal.While paliperidone is derived from Risperdal (risperidone), the oral medication qualifies as a new atypical antipsychotic, the FDA said. The tablet is slated to be launched by J&J’s Janssen unit in January.Analysts offered a mixed outlook for the drug, whose label included an unexpected warning that it could increase the risk of a potentially fatal heart side effect, QT prolongation. A similar warning has hampered uptake of Pfizer’s Geodon. Still, Invega’s warning is said to be less severe than Geodon’s, and analysts say J&J hopes to switch a large portion of Risperdal sales to Invega during the 18 months left before Risperdal goes off patent in 2008.A JP Morgan analyst forecasted Invega sales of $488 million in 2007, growing to $1.78 billion by 2009, noted CNNMoney.com.US sales of atypical antipsychotics reached $10.5 billion in 2005, according to IMS Health, with Risperdal accounting for $2.3 billion of that.Janssen also markets a long-acting injection form of risperidone, Risperdal Consta, which is given every two weeks. J&J said Invega is the first new FDA-approved treatment for schizophrenia since 2003 and the first to include information in its labeling about personal and social functioning, which are key issues for these patients and their families.
Janssen to launch Risperdal offshoot next month
The FDA approved Invega (paliperidone), a once-daily extended-release version of Johnson & Johnson's blockbuster schizophrenia drug, Risperdal.