The usefulness of a combination diabetes drug made by Sanofi SA’s is under preliminary review by the U.S. Food and Drug Administration following questions as to whether one component, lixisenatide, contributed to its benefit.
According to Reuters:
The French drugmaker is seeking approval for lixisenatide alone and as part of a combination product, iGlarLixi, which Sanofi hopes will establish a new paradigm for diabetes therapy by treating patients earlier and more aggressively.
The review comes ahead of a Wednesday meeting of an FDA advisory panel that will discuss lixisenatide and the combination treatment, iGlarLixi, an injection which delivers lixisenatide and Sanofi’s drug Lantus in a fixed-dose combination.
Regulators approved lixisenatide in Europe and Japan in 2013 where it is sold under the brand name Lyxumia.
Sanofi was given a quicker than normal review process after it purchasing a priority review voucher from Retrophin Inc for $245 million. The FDA gave Retrophin the voucher as part of a program to encourage more research into rare pediatric disorders.
“It is unclear whether there is a benefit in the low-dose range that balances the additional safety concerns from adding a second drug,” the division said, adding that trial may have created a bias in favor of the combination.
“The treatment difference observed may not reflect the actual treatment difference” they said.
FDA panelists will review whether the use of iGlarLixi should be approved for patients not treated with a basal insulin or a GLP-1, for patients who are inadequately controlled on either drug, or both, reports Reuters.