Lyxumia lixisenatide regulatory update

Sanofi said it will no longer market Type II diabetes drug Lyxumia lixisenatide in Germany after failing to agree on a price with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband). Sanofi said it may reexamine the move after a price for the glucagon-like peptide-1 receptor ( GLP-1R) agonist is determined through independent arbitration. Sanofi said Lyxumia's list price is €115.42 ($158.79) for a package of 28 daily doses, but declined to disclose details of the negotiations. In response to Sanofi's decision, GKV-Spitzenverband noted that there are a "wide range" of diabetes drugs available in Germany, including those which Germany's Federal Joint Committee (G-BA) has said have an additional benefit. In September, G-BA said in a final benefit assessment that Lyxumia has "no additional benefit" over comparators (see BioCentury, Sept. 9, 2013).

Last September, Sanofi withdrew an NDA for lixisenatide, which was under FDA review to treat Type II diabetes with an undisclosed PDUFA date. Based on discussions with the agency, Sanofi said it was concerned of potential public disclosure of interim data from the ongoing Phase III ELIXA cardiovascular outcomes trial, which were included in the NDA. The pharma said public disclosure could "compromise the integrity" of ELIXA. Final data from ELIXA are expected by the end of 2014, with an NDA resubmission expected in 2015 (see BioCentury, Sept. 16, 2013). The pharma has global commercialization rights to lixisenatide from Zealand under a 2003 deal. ...