Outside experts are preparing to review ustekinumab, Centocor's injectable treatment for severe psoriasis. Two Phase III studies demonstrated positive results, but staffers will have to consider possible increased risk of cancer associated with the drug. Animal studies indicated that the drug may encourage tumor growth. "Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients," FDA reviewers noted. Centoror, a division of Johnson & Johnson, is expecting an FDA decision by September.
Though ustekinumab may have produced impressive results in trials, J&J may have an uphill battle convincing insurers to cover the expensive drug for patients with severe forms of psoriasis. Insurers would prefer members to stick with older, cheaper psoriasis drugs rather than allow them to switch to one of the newer biologics that have hit the market.
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