FDA Staff Questions Usefulness of Sanofi’s Diabetes Drug Combo
- Agency staff raises concerns about clinical trial design
- Advisory panel meets Wednesday to vote on diabetes treatment
U.S. Food and Drug Administration staff raised concerns about the usefulness of Sanofi’s diabetes treatment that combines two medications and questioned the results of clinical trials designed to show the therapy is superior to insulin alone.
The dosing mechanism of the combined product might expose some patients to ineffective amounts of Lyxumia, one of the two drugs in the therapy, FDA staff said Monday in a report. Agency advisers will meet Wednesday to vote on whether to recommend approving the combination drug. FDA reviewers typically offer their analysis of clinical trials and any lingering concerns before such meetings. Sanofi’s injection is a combination of the company’s long-acting insulin Lantus and Lyxumia, which mimics a hormone called GLP-1 to stimulate natural insulin production. It is approved in Europe and not the U.S.