J&J's Centocor won a key vote by an FDA expert committee backing the approval of ustekinumab for moderate to severe psoriasis. But the experts also want to make sure that the developer continues studies exploring possible links between the drug and a heightened risk of cancer and infections [1]. The drug works by targeting the patient's immune system.
"This drug has the potential to be so helpful for patients, and I think it raises an ethical question if we keep it from them," said panel member Lynn A. Drake.
- check out this release [2]
- read the story [3] from Dow Jones
Related Articles:
J&J psoriasis drug may carry cancer risk [1]
Strong Phase III data for J&J's psoriasis drug [4]
Insurers shun new biologics for psoriasis [5]
Biotech drugs offer first real help for severe psoriasis [6]
Links:
[1] http://www.fiercebiotech.com/story/j-j-psoriasis-drug-may-carry-cancer-risk/2008-06-13
[2] http://www.fiercebiotech.com/press-releases/fda-advisory-committee-unanimously-recommends-approval-ustekinumab
[3] http://money.cnn.com/news/newsfeeds/articles/djf500/200806171929DOWJONESDJONLINE000623_FORTUNE5.htm
[4] http://www.fiercebiotech.com/story/strong-phase-iii-data-j-js-psoriasis-drug/2007-10-04
[5] http://www.fiercebiotech.com/story/insurers-shun-new-biologics-for-psoriasis/2007-01-24?utm_source=related&utm_medium=internal
[6] http://www.fiercebiotech.com/story/biotech-drugs-offer-first-real-help-for-severe-psoriasis/2005-12-20