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Ad Comm questions effectiveness of Sanofi's combo med for T2D iGlarLixi

May 23, 2016 12:15 PM ETSanofi (SNY) StockSNYBy: Douglas W. House, SA News Editor
  • Sanofi (SNY -1.6%) will need to be prepared to address pointed questions from Advisory Committee members on Wednesday related to the proof of efficacy of its fixed-ratio combination of insulin glargine and lixisenatide for the treatment of patients with type 2 diabetes (T2D).
  • The reviewers appear unconvinced that Sanofi's candidate, which combines a fixed-dose product, the GLP-1 agonist lixisenatide, with a product that requires titration on almost a continuous basis, insulin glargine, is as effective as deploying the drugs sequentially, i.e., on a "add-on" basis. All combination diabetes meds approved to date are either two fixed-dose products (e.g., two oral antidiabetics) or two titratable products (e.g. mixed insulins).
  • In clinical studies, Sanofi "transformed" lixisenatide into a titratable product. To establish the insulin component's contribution to the claimed effect, it compared the titration of the combination to a target fasting glucose goal to the fixed dose of the GLP-1 recommended as safe and effective. To establish the GLP-1 component's contribution to the claimed effect, Sanofi compared the combo product titration to doses of insulin also titrated to a target fasting glucose goal. The reviewers regard this issue as "problematic."
  • The reviewers also question the proposed dosage range of lixisenatide in the combination product since it includes doses that are not effective when used alone. Other areas drawing their attention are the perceived difficulty in switching patients to the combination without a significant reduction in the component they are on and potential medication errors due to the complexity of the combination (e.g., the use of two pens) and pen design (color scheme instead of a blocking mechanism to prevent under-dosing).
  • FDA briefing doc
  • Sanofi briefing doc
  • Erratum to Sanofi doc 

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