New study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease and all old investigation could be enough to support Dimebon’s approval for mild-to-moderate Alzheimer's disease.
Medivation provided an update on its pipeline candidates. The company said that it has finished enrolling patients (n=403) for its phase III HORIZON study that is being conducted with Dimebon for the treatment of Huntington's disease. Top-line results from this study should be out in the first half of 2011. The company will request a pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) if results are positive.
Meanwhile, the company said that it received a feedback from the FDA regarding the development of Dimebon for Alzheimer’s disease. Following the release of disappointing results on Dimebon from a pivotal phase III study (CONNECTION), Medivation has decided to streamline its development plans for Dimebon and is focusing on those trials which look more promising.
The agency has informed Medivation that robust results from the company’s ongoing CONCERT study along with data from an earlier study could be enough to support Dimebon’s approval for mild-to-moderate Alzheimer's disease. current
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