Issue 59 September 2013
7. Drug Updates

Sanofi withdraws application for U.S. approval of lixisenatide

Sanofi withdrew the application for U.S. approval of lixisenatide(Lyxumia). Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing Elixa study. The Elixa trial is comparing lixisenatide with a placebo in about 6,000 patients with Type 2 diabetes who recently experienced an acute coronary event such as a heart attack. The goal is to see whether the drug affects cardiovascular outcomes for patients. Sanofi will resubmit the application in 2015, after completion of the study. The withdrawal isn’t related to safety issues or deficiencies in the application. Lixisenatide belongs to a class of drugs known as GLP-1 analogues, which mimic the function of a digestive hormone that stimulates the pancreas to produce insulin after meals

Fate of Taspoglutide? – Results of the T-Emerge 2 Trial
Taspoglutide is a long-acting glucagon-like peptide 1 receptor agonist developed for treatment of type 2 diabetes. Overweight adults with inadequately controlled type 2 diabetes on metformin ± a thiazolidinedione were randomized to subcutaneous taspoglutide 10 mg weekly, taspoglutide 20 mg weekly, or exenatide 10 µg twice daily. Though once weekly taspoglutide demonstrated greater glycemic control than twice-daily exenatide with comparable weight loss there were unacceptable levels of nausea/vomiting, injection-site reactions, and systemic allergic reactions with taspoglutide. Discontinuations were greater with taspoglutide. Antitaspoglutide antibodies were detected in 49% of patients. Roche has now made the decision to stop the development of taspoglutide and to return the product to the originator, Ipsen, which is currently pursuing further investigations.

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