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FDA advisory panel recommends approval for Sanofi-Aventis’ iGlarLixi combination drug

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An FDA advisory panel has recommended approval of Sanofi-Aventis’ new drug application 208673 for insulin glargine and lixisenatide injection, to be known as iGlarLixi, for treatment of patients with type 2 diabetes.

The Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 in favor of recommending approval of iGlarLixi, a titratable fixed-ratio combination of basal insulin glargine 100 U/mL (Lantus) and lixisenatide, a glucagon-like peptide-1 receptor agonist.

“I voted ‘yes’ based on the concept that I think the combination of a GLP-1 agonist and insulin in one preparation that can be administered in one injection is going be helpful to patients and the clinicians who take care of them,” committee member Ellen W. Seely, MD, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. “My main issue was with the pen. Having the wording of the proposed pen in the vote was a struggle for me. The pen needs to be redesigned.”

Potential confusion surrounding the two pens used for the combination product was a matter of concern for several committee members. Seely additionally noted that patients with colorblindness or decreased macular function due to age may have difficulty distinguishing the pens.

iGlarLixi was developed to combine the benefits of insulin glargine, which mainly addresses fasting plasma glucose, and lixisenatide, which primarily yields reductions in postprandial plasma glucose; iGlarLixi is provided in two different pens. The two titratable pens are available to be used as follows:

• Insulin-naïve 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, and the green/olive pen for total daily doses of 41 to 60 U.

“I voted ‘no’ solely on the pen design,” committee member Kenneth D. Burman, MD, director of the endocrine section at MedStar Washington Hospital, said. “I was concerned with the results of the human factor study. I do think the evidence otherwise supports that this agent is effective and safe in the vast majority of patients. I think the advantages outweighed the disadvantages, other than the pen.”

An FDA human factors 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.

Concerns were also expressed regarding allergic reactions, anaphylaxis and cross-reactive antibodies, and some committee members voted yes contingent on post-market studies in these areas. Members also requested additional data regarding the use of iGlarLixi in patients already taking a GLP-1 agonist.

During the public portion of the meeting, American Diabetes Association Chief Scientific and Medical Officer Robert E. Ratner noted that while the ADA does not speak in favor of specific products, he commended the FDA for its consideration of newer agents for type 2 diabetes.

“We strongly support the need for further research and approved therapies for an unmet need,” he said.

The new drug application submission for iGlarLixi is based on data from two phase 3 studies involving more than 1,900 patients worldwide. The studies evaluated the safety and efficacy of the combination product when used in patients inadequately controlled with oral antidiabetic agents and in patients insufficiently controlled after basal insulin therapy. Both studies met their primary endpoints. According to the Sanofi press release, the company anticipates an FDA decision on iGlarLixi in August.

Because Sanofi-Aventis’ lixisenatide also is under review, the FDA requested that the company also provide overview of the risks and benefits of that agent.

According to committee member Peter Wilson, MD, iGlarLixi represents another potential valuable tool in the fight against diabetes.

“This provides yet another choice, and I think choice is very important or physicians and for patients,” he said.  “I think this will be a boon for the patients.” – by Jennifer Byrne