The FDA has asked Zafgen to hit the brakes on its mid-stage study of an experimental diabetes treatment.
The company announced Monday that the agency cited the risk “possibility of cardiovascular safety” associated with the drug, ZGN-1061, in its decision. Although no adverse effects have been reported from the study so far, the FDA based its concerns on deaths from two years ago linked to a Zafgen obesity drugs that reportedly acts in a similar way to ZGN-1061.
Boston-based Zafgen develops treatments for complex metabolic disorders.
The company said it plans to meet with the FDA soon to discuss how to move the clinical trial forward.
Read the Reuters report.