Sanofi Withdraws Lyxumia Submission from the FDA, Plans for Resubmission in 2015

On September 12, Sanofi announced that it withdrew the FDA application for its once-daily GLP-1 agonist lixisenatide (named Lyxumia in Europe) for type 2 diabetes. It is a new drug in the same family as Byetta/Bydureon and Victoza. Lyxumia now likely won’t be available in the US until 2016 at the earliest, even though it has been approved in Europe since February 2013.

The FDA was originally expected to rule on Lyxumia by the end of 2013 with interim data from ELIXA (mid-term data collected while the trial is still running). The drug was withdrawn to allow Lyxumia’s cardiovascular outcomes trial ELIXA to run to completion before a final FDA ruling. ELIXA is expected to report results in 2015, meaning an FDA decision on Lyxumia will likely be delayed until at least 2016. A cardiovascular outcomes trial is required by the FDA to ensure that a drug doesn’t increase patients’ risk of heart disease.

Sanofi emphasized that the withdrawal was not related to safety issues or to problems with the drug application — rather, it worried that the FDA’s review process might jeopardize the integrity of the ELIXA trial if the interim data were released. Trial data released to the public could affect how health care providers and participants in the study behave during the rest of the study and bias the final results. Therefore, Sanofi would run the risk of invalidating the (very expensive) trial if it disclosed interim data now. This decision highlights the sizable challenges of conducting a long-term trial while pursuing regulatory approval of a new drug*.

For more information on Lyxumia and GLP-1 agonists, please read our new now next in diaTribe #52. LixiLan (an exciting combination of lixisenatide and the basal insulin Lantus) is still on schedule to begin phase 3 testing in the first half of 2014. LixiLan’s FDA review is dependent on the approval of Lyxumia, so while Sanofi has not commented directly on LixiLan’s timeline, it is likely that the earliest it could receive approval in the US will now also be 2016. – NL/JD/MV

* For example, Novo Nordisk has been developing its basal insulin degludec for over 10 years at a cost of more than $1 billion – the drug was not moved forward by the FDA, although other regulatory agencies worldwide have approved it.