The New England Journal of Medicine has laid out the data from a cardiovascular outcomes trial of Sanofi's GLP-1 diabetes hopeful Lyxumia, and the good news for the French drugmaker is that the drug didn't raise the rate of major cardiovascular events in patients with acute coronary syndrome. But it didn't lower it, either.
Back in June, researchers unveiled details of the ELIXA trial, which put Sanofi's Lyxumia in the clear as far as cardiovascular safety risks go. Now, a new analysis of the study shows that in Type 2 patients with acute coronary syndrome, the diabetes med didn't increase the rate of cardiovascular events--but it didn't decrease it, either.
Some industry watchers are wondering whether those large, expensive trials--which aren't long enough to establish long-term outcomes--were worth it.
Sanofi can go back to the FDA with Lyxumia. The French drugmaker got good news from a cardiovascular outcomes study, required by the FDA before it would approve the diabetes drug.
Sanofi's new diabetes drug hit a setback in Germany. The country's increasingly strict pricing regulators say Lyxumia delivers "no additional benefit" compared with existing drugs. If the decision sticks, then Sanofi would lose the power to price Lyxumia at a brand-name premium.
Sanofi is making a case for why its experimental diabetes drug Lyxumia stands out from existing GLP-1 therapies, as the French drug giant eyes the new med to build up its Lantus-led diabetes franchise amid relentless competition.
In one of the worst kept secrets in the industry, Sanofi has been in the scrum of potential buyers forming around Amylin in recent weeks.