On Friday, Johnson & Johnson’s Centocor Ortho Biotech division received approval for Stelara (ustekinumab) for the treatment of psoriasis. It’s new mechanism of action, which is probably why the FDA spent over two years reviewing the drug. So much for PDUFA deadlines.
Stelara offers quarterly dosing every 12 weeks, with equivalent efficacy to other drugs on the market.
So the real question is – what took so long? Was J&J distracted in its internal merger of Centocor and Ortho Biotech? Was J&J slow in its responses to the FDA? Was the hang-up at the FDA due to the new mechanism of action? I think it’s safe to say that it has been many years since I’ve seen a review take this long at the FDA.
There are some pretty significant adverse events with Stelara that patients should be aware of – including an increase in the risk of cancer. Stelara has also been associated with at least one case of reversible posterior leukoencephalopathy syndrome (RPLS) – a rare condition that can affect the brain and might lead to death.
In Canada, Stelara costs between CAN $18,000-$33,000 a year. Individual patient costs in the U.S. will depend on formulary adoption. Given the number of other options on the market, it will be interesting to see what kind of up-take J&J/Centocor Ortho Biotech will get. J&J is expecting sales of half billion in the next few years.
Reference: Reuters and J&J Press Release
