Promising Psoriasis News at FDA, with Severe Risks
A U.S. FDA panel voted on Tuesday to recommend the FDA approval for a proposed Johnson & Johnson (NASDAQ: JNJ) drug called ustekinumab proposed to treat severe-to-moderate psoriasis. This might be good news but it is not without risks and we don’t just mean to the patients taking the drug.
While this is positive, it is far from a slam dunk. The FDA panel expressed concerns about the drug’s increased cancer risk. It also wants the longer-term data and there sounds like there is much caution out of this panel despite the nod. As a reminder, the FDA does not always vote in favor of a drug approval just because the preliminary FDA Panel recommended a drug for approval.
Psoriasis is a skin disease with dry and cracked skin with red patches that counts more than seven million Americans alone as the current patient group. It can range from mild to debilitating depending on the cases. There is still no cure for psoriasis and most treatments on the market today are mildly effective so far. For the risks of this drug being increased risks of cancer, they are going to have to only offer this up for the severe cases in patients who are willing to take the risks.
The company that can come up with an effective treatment that has few side effects has a mega-blockbuster on its hands. Unfortunately, that is a big hurdle right now.
Jon Ogg
June 17, 2008