LONDON, UK (GlobalData), 17 September 2013 - Sanofi’s decision to withdraw Lyxumia’s New Drug Application in the US might have come as a surprise for some industry observers; but this move might prove successful in the near future, says an analyst with research and consulting firm GlobalData.
In a statement, the pharmaceutical company cited its fear that the FDA’s review of the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study would compromise the integrity of this large ongoing cardiovascular outcomes trial. The ELIXA study began in 2010 and aims to evaluate the cardiovascular risk profile of Lyxumia in patients with type 2 diabetes who have recently had an acute cardiac event and have high cardiovascular risk.
Valentina Gburcik, Ph.D., GlobalData’s Analyst covering Cardiovascular and Metabolic Disorders, says: “Growing demands from the FDA have prompted Sanofi, and other drug developers, to engineer massive clinical trial programs for new diabetes drugs to show their impeccable cardiovascular safety profiles.”
Gburcik believes that revealing the interim results from the ELIXA study prior to its completion could ruin potential major opportunities for the drug.
“This trial is very important to Sanofi, not only because of the tough FDA regulations, but also because one of the main opportunities in the type 2 diabetes market is the development of a drug that addresses not only glycemic control but also cardiovascular complications,” says Gburcik. The current anti-diabetes drug market is becoming increasingly competitive as new players emerge, such as Bristol-Myers Squibb/AstraZeneca’s Bydureon, and other upcoming once-weekly GLP-1 agonists, such as GSK’s albiglutide, Eli Lilly’s dulaglutide and Novo Nordisk’s semaglutide, which are currently in Phase III development.
While Gburcik does not anticipate that Lyxumia will take the type 2 diabetes market by storm when it launches around 2016, she believes it stands a better chance of doing so with more robust trial data.
- Comment provided by Valentina Gburcik, Ph.D., GlobalData’s Analyst covering Cardiovascular & Metabolic Disorders. For guidelines on how to cite GlobalData, please see: http://www.globaldata.com/QuotingGlobalData.aspx
-ABOUT GLOBALDATA-
GlobalData is a leading global research and consulting firm offering advanced analytics to help clients make better, more informed decisions every day. Our research and analysis is based on the expert knowledge of over 700 qualified business analysts and 25,000 interviews conducted with industry insiders every year, enabling us to offer the most relevant, reliable and actionable strategic business intelligence available for a wide range of industries.
For more information, please contact our Press Office on +44 (0)1204 543 528 or at pr@globaldata.com.
Help employers find you! Check out all the jobs and post your resume.
