After years of delay, drug maker Sanofi is almost ready to resubmit its type 2 diabetes treatment lixisenatide for Food and Drug Administration (FDA) approval, armed with a long-term study that the company hopes will squash any safety concerns posed by FDA panel advisors.
Lixisenatide, which is already approved in Europe and marketed under the name Lyxumia, is a GLP-1 agonist that works similarly to already marketed drugs Byetta and Victoza. The drug was originally under review by an FDA advisory panel in 2013, but after Novo Nordisk’s GLP-1 drug was rejected due to safety concerns, Sanofi opted to pull lixisenatide’s application to better establish the drug’s safety.
It’s taken two years, but the data is now in and Sanofi says it is pleased enough with the results to resubmit the drug for FDA approval. The new data includes five years of research involving more than 6,000 diabetic patients, and shows patients taking lixisenatide were no more likely to suffer heart attacks, strokes or other cardiovascular events than those taking a placebo. They were also not at increased risk of heart failure, pancreatitis, pancreatic cancer or hypoglycemia.
The results are reassuring considering the FDA is already reviewing safety concerns in patients taking currently approved GLP-1 drugs including Byetta and Victoza. Byetta has been associated with 1,900 cases of a painful inflammation of the pancreas known as pancreatitis, and more than 1,200 have been reported with Victoza. A similar type 2 diabetes med, Januvia, was linked to nearly 1,300 cases of pancreatitis.
Byetta, Victoza, Januvia and Janumet (a combination of Januvia and metformin) have been also been linked to hundreds of cases of pancreatic cancer, one of the deadliest forms of cancer.
Sanofi says it plans to resubmit lixisenatide for FDA approval before the end of the year.