• 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.

Patients already being treated with Lyxumia or Lantus alone can’t easily switch to the combined product, FDA staff said. They also questioned the usefulness of putting patients on two medications when one may be enough, and said the design of the pen used to deliver the treatment could lead to dosing errors.

Trial Questioned

FDA staff also questioned the results of a clinical trial testing Sanofi’s product. The combination wasn’t compared to the most effective doses of Lantus alone for some patients, the report said.

“Inadequate dosing of the insulin in the studies could have biased the estimate of efficacy in favor of the combination product,” FDA staff wrote. “This would further confound interpretability of a clinical superiority claim for the combination against the insulin comparator.”

A separate FDA report released Friday found that Novo Nordisk A/S’s approach to testing a similar combination may have skewed the results, leading to concerns that Novo didn’t adequately show that its own injection works better than a long-acting insulin alone. Both companies are in a race to become the first to get similar treatments to market. The same advisory panel will meet Tuesday on Novo’s drug, which the company has proposed to call Xultophy.

Although Sanofi filed for approval three months after Novo, it benefited from a voucher for sped-up FDA review. The agency is scheduled to decide whether to approve Sanofi’s shot by Aug. 23. While Novo hasn’t given a specific date for an FDA decision, it may come in the third quarter of 2016 if the outcome of Tuesday’s advisory panel meeting is positive, according to Sam Fazeli, a Bloomberg Intelligence analyst.

Diabetes affects about 29 million people in the U.S. and is the seventh-leading cause of death, according to the National Institutes of Health. About 90 percent to 95 percent of U.S. adults diagnosed with the disease have the type 2 version, which occurs when cells respond poorly to insulin.

If approved, Sanofi’s shot is expected to reach $574 million in sales in 2020, according to analysts’ estimates compiled by Bloomberg.

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