FDA Wants More Clinical Data On Cinryze Drug
June 4, 2009 by admin
The Food and Drug Administration (FDA) have sent a complete response letter to ViroPharma concerning their experimental drug, Cinryze.
The drug was developed to treat a rare genetic medical condition, but according to the FDA the company have not proven that it can be used as an effective treatment.
The FDA is requesting more information pertaining to the drug, via the conducting of an aditional clinical trial with more pronounced data.
“The U.S. Food and Drug Administration has requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the supplemental Biologics License Application lacked robustness,” the company said in a statement.
Last year Cinryze was approved by the FDA to treat hereditary angioedema and the company is looking to expand the approval to include acute attacks of the condition.
