Valeant psoriasis drug safety challenging to assess -FDA Staff
July 15 (Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat the skin disorder psoriasis carries several potential risks that are challenging to assess due to limited controlled data, a preliminary review by the U.S. Food and Drug Administration.
The review comes two days ahead of a meeting of outside experts who will advise the FDA on whether the drug should be approved. The agency is not obliged to follow the advice of its advisory panels but typically does so.
Some patients in clinical trials committed suicide and the agency said no risk management strategy will completely eliminate the risk of suicide and suicidal thoughts seen with the drug, broadalumab. (Reporting by Toni Clarke in Washington)
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