New Phase-IIIb data about Sanofi’s diabetes drug Lyxumia (lixisenatide) show that the drug may have flexible dosing on its side. The drug met the target of “non-inferiority in blood-sugar lowering” regardless of whether it was taken before breakfast or during what Sanofi calls “the main meal of the day,” which ended up being lunch for 53% of the patients in the 451-person clinical trial.
The daily GLP-1 injection is already marketed in Europe, Mexico, Australia and Japan, among other countries, but is in waiting mode in the US. The company pulled its FDA review request in September, saying it wanted its Elixa cardiovascular study to be completely wrapped before offering the drug up for US regulatory review.
