Janssen applies for Olysio label expansion

Johnson & Johnson's (JNJ +1%) Janssen Pharmaceuticals unit submits an sNDA to the FDA for the use of Olysio (simeprevir) with Gilead Sciences' (GILD -0.2%) NS5B polymerase inhibitor sofosbuvir for the treatment of genotype 1 chronic hepatitis C in adult treatment-naive patients with advanced fibrosis and null responders with all stages of fibrotic disease. The product is currently approved as a combination therapy with peginterferon alfa and ribavirin as a treatment for HCV-1 for compensated liver disease including cirrhosis.

The company's regulatory submission is based on data from the Phase 2 Optimist trial which included the fibrosis and null-responding patients cited above.

Last month, Janssen started a Phase 3 trial to examine the safety and efficacy of simeprevir and sofosbuvir without interferon or ribavirin for the treatment of HCV-1 patients.

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Comments (4)
  • GaryStoltz
    , contributor
    Comments (28) | Send Message
    I'm one of the patients familiar with this combination. So far NO side effects and the dose is one of each a day. This is a home-run!
    7 May 2014, 01:40 PM Reply Like
  • :-) ;-)
    , contributor
    Comments (541) | Send Message
    Speaking of costs, wouldn't this make treatment prohibitively expensive? Also, I know someone who was in the Sofosbuvir/Ledipasvir trials. Twelve weeks, no Interferon, few side-effects. When it is FDA approved in October, I can't imagine it won't dominate the market.
    7 May 2014, 04:09 PM Reply Like
  • garydex
    , contributor
    Comments (2) | Send Message
    The Sovaldi (Gilead) is $1,000 per pill for a total of $86,000 and the Olysi (Johnson & Johnson) is another $64,000 for the 12 week long treatment. I think the word greed is appropriate in this conversation. Jonas Salk gave his polio vaccine to mankind and didn't receive one red cent for it! I will soon line up for my treatment, if my insurance will pay.
    8 May 2014, 03:32 AM Reply Like
  • Camman1963
    , contributor
    Comments (76) | Send Message
    Nothing against Jonas Salk (great man), but perhaps if he had charged for his vaccine and used the revenue to create a large pharma, he would have built a great company like GILD that would have cured many more diseases. That was his choice, but you can't force that choice on other companies or think that there is not a down-side to his approach too.


    Business 101: never charge what it cost you to produce something, but on the value it brings to the customer. I am amazed that people will spend $50K on an SUV, or $100K on a bigger house than they need, but grouse about a life-saving/life-altering treatment. If you truly cannot afford the cure, there will be ways of getting it at reduced price.


    GILD deserves to make a lot of money and they will. They will use that money to fund more research and wipe from the planet other deadly diseases. Long Gilead.
    8 May 2014, 10:49 PM Reply Like
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