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FDA requests, receives more data for iGlarLixi combination pen
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The FDA has requested and received additional information regarding pen delivery service for a combination insulin glargine and lixisenatide injection, Sanofi announced in a press release.
The major amendment to the new drug application for the combination, known as iGlarLixi, will result in an extension of the Prescription Drug User Fee Act goal date by 3 months, to November 2016, the company said.
“Sanofi appreciates the feedback from the FDA on the delivery service and believes that the information submitted will result in an offering that will serve the needs of adults living with type 2 diabetes,” Sanofi said in the statement. “The company looks forward to hearing from the FDA once the review of the updated information has been completed.”
An FDA advisory panel voted 12-2 in May in favor of recommending approval of iGlarLixi, a titratable, fixed-ratio combination of basal insulin glargine 100 U/mL (Lantus) and lixisenatide (Adlyxin), a glucagon-like peptide-1 receptor agonist that was approved by the FDA in July.
The combination is provided in two different pens, available to be used as follows:
Insulin-naive patients should initiate treatment at a recommended daily insulin glargine (100 U/mL) dose of 10 U with a corresponding dose of 5 g of lixisenatide (yellow/peach pen).
In patients switching from basal insulin to iGlarLixi, two different starting doses are available depending on previous insulin need — either the yellow/peach pen (20 U/10 g) or the green/olive pen (30 U/10 g), thus avoiding a significant reduction in their current insulin dose.
The dosing of iGlarLixi is adjusted based on the need for basal insulin. After the product has been started and during titration, the yellow/peach pen is used for total daily insulin glargine doses of 10 to 40 U; the green/olive pen is for total daily doses of 41 to 60 U.
Panel members in May expressed concern regarding the pen designs, citing an FDA human factors study. That study found that although 14 out of 15 pharmacist participants selected the correct caption when presented with a prescription for either of the pen options, one pharmacist selected the wrong pen after overlooking the numerical modifier in the proposed proprietary name.