In an unexpected move, Sanofi (SNY) has withdrawn its application for its lixisenatide diabetes drug with the FDA over concerns that “potential public disclosure” during the agency’s review of interim trial data could compromise the “integrity” of an ongoing study. The drug maker, though, insists its decision is unrelated to any safety issues concerning the drug or any deficiencies in its new drug application.
Instead, Sanofi plans to resubmit the application in 2015, after its Elixa study is completed in about 15 months. At the same time, the drug maker told employees this morning that the additional 200 to 300 sales reps that were hired and being groomed to eventually market the drug would remain on staff, according to sources. A Sanofi spokesman declined to comment.
The decision is a clear setback for Sanofi, which has been struggling to broaden its diabetes franchise amid tough competition. Although lixisenatide was not seen as a game changer – the once-daily drug is a GLP-1 inhibitor and, essentially, is another example of a me-too medicine – the withdrawal suggests interim results yielded problems, according to David Kliff of Diabetic Investor.
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“Since no one but Sanofi and the FDA knows what the CV data is, today’s decision tells us the data wasn’t good,” he writes in a client note in which he called the withdrawal “a stunning turn of events.” “…It’s overstating the obvious that this is just another failure in their diabetes franchise which for all practical purposes is now a one trick pony: Lantus,” the long-acting and best-selling insulin.
The drug is actually marketed elsewhere in the world under the Lyxumia brand name, but FDA approval would have meant that Sanofi could have jointly promoted Lixisenatide with Lantus. In fact, combining the two drugs is a long-range strategy and Sanofi made a point of saying today that a Phase III combination trial remains on track to begin in the first half of next year.
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Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at firstname.lastname@example.org. Read the RIABiz profile of YCharts. You can also request a demonstration of YCharts Platinum.