Experimental psoriasis treatment delayed
Xanelim won't be submitted for government approval until summer 2002
First posted Oct. 5, 2001
New tests requested by the U.S. Food and Drug Administration (FDA) will delay efalizumab (brand name Xanelim), an experimental biotech agent for the treatment of moderate to severe plaque psoriasis. Genentech and Xoma, the drug's manufacturers, had said Xanelim would be filed for FDA approval in late 2001 or early 2002, but the submission to the FDA is now slated for summer 2002.
Extensive clinical trials have been completed to test the effectiveness and safety of Xanelim, which is delivered by injection. (Read about the phase III trial results, as reported at the International Psoriasis Symposium, held June 19-24, 2001, in San Francisco.)
However, the FDA wants a study conducted to ensure the Xanelim that will be mass-produced for use by the public is chemically equivalent to the Xanelim that was made in smaller batches and used in clinical trials. To accommodate large-scale production, Genentech and Xoma said "minor manufacturing modifications" were made to Xanelim. The FDA was aware of the changes and previously approved them, but now an equivalency study in humans has been mandated.
Xanelim is one of a group of promising new biologic therapies being developed for psoriasis. Most of them target specific immune reactions within the body that are believed to lead to the accelerated skin cell growth characteristic of psoriasis. By narrowly targeting these reactions, the new biologics hold the promise of being effective at improving psoriasis but with fewer risks and side effects for patients.
It was anticipated that Xanelim would be among the first of new agents to reach the market, but approval would now come in mid to late 2003, at the earliest.
The clear leader in the race to approval is Biogen's alefacept (pronounced uh-LEF-uh-sept, and also known by the brand name Amevive), which was submitted to the FDA in August 2001. Consumers will probably have to wait until late 2002 before they can get Amevive; it can take the FDA a year or longer to review a new treatment application.
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