Lyxumia's CV results may help Sanofi's case for approval, but they won't score it points against SGLT2s

The New England Journal of Medicine has laid out the data from a cardiovascular outcomes trial of Sanofi's ($SNY) 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.

Results published Thursday show that 406 Lyxumia patients--13.4%--recorded a heart attack or stroke, were hospitalized for unstable angina, or died of cardiovascular causes, compared with 399 patients on placebo, or 13.2%. There were no significant differences in the rate of hospitalization for heart failure, either, and Lyxumia didn't increase serious side effects such as pancreatitis.

Confirmation that the drug is safe is just what Sanofi was looking for when it pulled its Lyxumia FDA application back in 2013. At the time, the agency was tightening up on diabetes newcomers--wary of another safety scandal like the one spurred by GlaxoSmithKline's ($GSK) Avandia--and Sanofi decided to hold back until it had positive results from a CV outcomes trial.

Problem is, since then, a drug from another class--Eli Lilly ($LLY) and Boehringer Ingelheim's SGLT2 entrant Jardiance--has shown it can do one better. In September, the partners rolled out data showing their med had cut the combined risk of heart attack, stroke, and death from cardiovascular causes by 14% in high-risk diabetes patients.

But while those findings may heat up the competition, they don't necessarily mean doom for Lyxumia and its fellow GLP-1s--or other diabetes classes, for that matter. As Peter Stein--VP of clinical research in diabetes and endocrinology at DPP-4 powerhouse Merck--told FiercePharma earlier this year, "patients with diabetes need more than one agent, and often more than two agents, to get to goal."

And earlier this week, Novo Nordisk ($NVO)--maker of GLP-1 superstar Victoza, which will compete with Lyxumia if Sanofi wins approval--unveiled a new meta-analysis showing that its med beat SGLT2s at reducing the blood sugar metric HbA1c. The analysis of 17 controlled trials suggested that patients using Victoza had a better chance of hitting their blood-sugar goals, too.

Sanofi, for one, will have to hope its CV results don't set it back if and when it reaches the marketplace. Its diabetes sales are sagging already, and last month, the company announced plans to cut $1.6 billion in costs and hive off its animal health and European generics businesses to offset their drag on profits.

- read the results in the NEJM

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