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news.The FDA has informed Medivation that the company will have to perform further toxicology studies of its Huntington's disease drug candidate, Dimebon, before it can begin testing the compound in humans.
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The agency’s decision comes in response to Medivation’s investigational new drug application (IND), which was filed on January 31, 2006.
“Based on the information we have from FDA thus far, we believe we can complete the requested studies in a few months. Obviously our Huntington’s disease program will be delayed somewhat and, if resource reallocation is required, our prostate cancer program may also be delayed. We remain on track for the previously disclosed milestones for our lead clinical program in Alzheimer’s disease,” said Dr David Hung, president and CEO of Medivation.
The company has so far only spoken with the FDA about this issue in a telephone call, but the FDA will shortly send an official letter to confirm its decision. The company will then formally consult with the agency before deciding on its best course of action.