Says the news will not ultimately effect sales:
http://pharmagossip.blogspot.com/2008/06/uh-oh-tnf-trouble.html
No comments posted there on this yet, but let's keep checking.....
If you click on "More", you get this:
"The anti-TNFs have been available for around 10 years and have
proved to be a successful drug class in the treatment of autoimmune
disorders. Datamonitor estimated that the TNF class achieved total
sales of around billion in the seven major markets in 2007; around
75% of the sales came from the US market.
However, during this
10 year timeframe, use of TNF blockers in children has yielded 30 cases
of cancer including leukemias and melanomas. About half the reported
cases were Hodgkin's and non-Hodgkin's lymphomas but it is also
important to point out that the child patients received concomitant
immunosuppressants such as methotrexate, azathioprine or
6-mercaptopurine, which carry a known cancer risk. The FDA will review
the cancer risk over six months, but UCB will need to provide long-term
safety data for Cimzia, which it will run from 2009 for 10 years, as
there is currently a lack of data because it is a new product.
Although
the FDA needs to be seen to take steps to assess cancer risk with
anti-TNF therapies, Datamonitor's view is that it is not a new cause
for concern. The FDA and physicians are already familiar with the risk
of cancer with these agents. Indeed, all four TNF agents carry cancer
warnings in their prescribing information.
The news of the
safety review might have a small, but negligible, impact in some
physician groups who prescribe anti-TNFs in under 18s. However, these
therapies will remain important, effective treatments and ultimately
Datamonitor expects most physicians will continue their use in the
near-term with no large impact on brand sales. The ability of the
physician to assess the risk-benefit ratio and communicate risk will be
even more crucial and is the most important short-term requirement as a
result of this news.
Source: Datamonitor"