Study results positive for new drug
First posted May 31, 2001
Based on preliminary analysis, the experimental psoriasis drug efalizumab (brand name XanelimTM) was reported to be successful in two late-stage clinical trials. According to a press release from Genentech, Inc., and XOMA Ltd., the companies co-developing Xanelim, two phase III studies met their primary endpoint: more patients treated with the drug had 75 percent or better improvement in their psoriasis, compared to patients treated with placebo.
More specific data was not released from the 12-week studies, which involved more than 1,000 patients with moderate to severe psoriasis in the U.S. and Canada. Patients received one of two doses of Xanelim or placebo by weekly injections. Xanelim was reported to be well tolerated, but side effects observed during the trials included mild-to-moderate headache, nausea, chills and pain.
Phase III clinical trials are large-scale studies to confirm the effectiveness and safety of a drug. They are usually the last stage of clinical research conducted before companies seek approval for their drug.
Additional studies are being conducted to evaluate the drug's long-term side effects and its ability to maintain symptom improvement with continuous use.
It has been reported in the media and the NPF has heard anecdotally -- from both patients and physicians involved in studies of Xanelim -- that in some cases, psoriasis comes back quickly after patients stop taking the medication. This may indicate that some patients will need to stay on the drug for long periods of time to maintain the improvement or clearing of their skin.
Therefore, the studies of Xanelim's long-term safety are considered very important, and some researchers view them as critical to the drug getting approved by the U.S. Food and Drug Administration (FDA) (see the article linked below for more details).
Pending additional analysis of their phase III data, Genentech and Xoma say they will decide by the end of 2001 or in the first quarter of 2002 if and when Xanelim will be submitted for approval to the FDA. The agency can take a year or more to review a drug application.
Targeting the immune system
Xanelim is a humanized monoclonal antibody designed to block a key immune-system reaction involved in the development of psoriasis. It is part of a new generation of targeted therapies that selectively fight psoriasis at the cellular level. These drugs have the potential to be more effective and safer than the treatment options now available to people with moderate to severe psoriasis.
The NPF is closely tracking the development of these exciting new therapies. Visit this Web site often for updates as they become available.
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