Medivation says FDA will require additional toxicology testing, may delay trials

By Elaine Rigoli

Tampa, Fla., March 1 - Medivation, Inc. received news late Tuesday that the Food and Drug Administration will require additional toxicology testing before human clinical trials can begin on Dimebon for Huntington's disease.

This decision may delay the Huntington's disease program, according to a company news release.

In the call, the FDA stated Medivation would be required to conduct additional toxicology studies prior to receiving approval to start its proposed human clinical trial, according to the release.

Medivation had filed an Investigational New Drug application on Jan. 31.

The FDA also informed Medivation that it would be sending a written comment letter.

"We have not yet received the FDA's comment letter or had the opportunity to discuss our IND with the FDA staff. Once we receive the letter and have the opportunity to consult with the FDA staff, we will formulate a plan in consultation with the staff," said David Hung, MD, president and chief executive officer, in a company statement.

"Based on the information we have from [the] 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."

San Francisco-based Medivation is a pharmaceutical and medical device technologies company.

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