As we noted here late last year, there are several promising new Alzheimer's treatments in the FDA pipeline. While the early stages of the pipeline are predictably more full than the later stages, we expect to see data this year on at least two agents that are nearing the end of the trial process.
Earlier this week, Baxter announced the successful conclusion of their futility analysis on IVIG for treating symptoms in mild to moderate stage Alzheimer's patients. The futility analysis, conducted by the Data Safety and Monitoring Board (DSMB), indicated that further trial efforts could proceed with no modification to the protocol. With that result, Baxter immediately announced plans to initiate a confirmatory Phase III trial to begin in early 2012.
IVIG, or intravenous immunoglobulin, has been marketed for some 25 years to treat autoimmune diseases, but has not previously been studied and approved for treating Alzheimer's disease. Given it's historical safety profile and early data indicating efficacy in Alzheimer's patients, it may be the next drug approved in this field.
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