FDA Sets the Stage for Earlier-Stage Alzheimer's Treatments

The U.S. Food and Drug Administration has proposed guidelines to lower the clinical study goals of Alzheimer's disease drugs for treating earlier-stage subjects who have yet to exhibit functional disability or clinical abnormality, reports NASDAQ . This strategy suggests the agency may be amenable to an expedited approval process for such drugs. The proposal follows major Alzheimer's drug failures, including those for verubecestat and BAN2401. In January, Pfizer reportedly announced the discontinuation of its research and development efforts in the Alzheimer's and Parkinson's disease areas, while much earlier the company shelved its late-stage Alzheimer's candidate, bapineuzumab IV, after it failed two phase III studies. Last November, Lilly's LLY anti-amyloid candidate solanezumab did not meet the primary endpoint in a late-stage Alzheimer's study, and Lilly opted to terminate the development of solanezumab. The drugmaker also experienced a major setback in August 2010, when it had to stop development of another phase III Alzheimer's candidate, semagacestat.