FDA Panel Backs New Psoriasis Drug
Experts Say Benefits of Ustekinumab Outweigh Potential Long-Term Risks of Cancer
June 17, 2008 -- Experts told the FDA Tuesday that it should approve an experimental psoriasis drug despite evidence the drug may cause cancer after long-term use.
The medication, called ustekinumab, has been shown to reduce the itchy and scaly symptoms of the moderate and severe forms of the skin disease psoriasis. But FDA scientists also expressed concern over animal studies showing the drug can promote lymphoma.
In a 9-1 vote, with one abstention, an FDA advisory panel said the benefits of the drug outweigh the potential risks of cancer. That was after experts said the manufacturer had not studied the drug sufficiently to know its long-term cancer risks. The FDA doesn't have to follow its panels' recommendations, but it usually does.
Efficacy Sways Panel
Panelists said they were ultimately convinced by ustekinumab's demonstrated ability to relieve psoriasis, a disease with devastating psychological consequences for many of the estimated 8 million Americans who suffer from it -- a factor most said outweighed a theoretical risk of cancer.
"The remarkable efficacy I think is a very convincing factor," said Arthur Levin, MPH, director of the Center for Medical Consumers and a member of the expert panel.
"If you concentrate on risk-benefit compared to almost everything else we have available, the drug looks pretty good," said Michael Bigby, MD, the panel's chairman.
Ustekinumab works by targeting inflammatory chemicals called interleukins which are elevated in patients with psoriasis. That helps cut down on the inflammation at the root of many psoriasis symptoms. A pair of trials by manufacturer Centacor, a division of Johnson & Johnson, showed the drug can reduce redness, itching, and skin flaking, and the panel voted unanimously that the drug is effective.
Most patients also have to take ustekinumab injections only every three months, a far less frequent schedule than with other drugs, the company said.
But inhibiting the chemicals could also play a role in promoting cancerous tumors. Studies in mice that showed use of the drug can promote lymphoma cancers were a concern to FDA scientists.
"Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients," the FDA told its advisors in briefing documents this week.