NEW ORLEANS--As Sanofi’s top-selling Lantus careens toward its first U.S. biosimilar competition in December, the French drugmaker has been developing not only a follow-up diabetes product--the longer-acting Toujeo, FDA-approved last year--but also a combination therapy that pairs Lantus with its GLP-1 drug lixisenatide.
Sanofi ($SNY) rolled out details on Sunday from two pivotal trials that tested the med--internally referred to as LixiLan--in patients with Type 2 diabetes. LixiLan hit its primary endpoints in both trials by delivering better blood glucose control than its constituent parts.
The two drugs "work in a complementary manner," Dr. Rachele Berria, Sanofi VP and head of its diabetes medical unit, told FiercePharma at the American Diabetes Association's Scientific Sessions Sunday. She noted that basal insulins--such as Lantus--decrease fasting glucose levels, while lixisenatide works better on blood sugar control after meals.
Plus, patients on the combo lost weight or, at the least, saw no change in weight, Berria said, where weight gain is a key side effect of basal insulin. "We think this drug will have an impact on many patients struggling with diabetes," she said.
LixiLan would compete head-to-head with a similar combo from Novo Nordisk ($NVO), which marries its basal insulin Tresiba with the GLP-1 blockbuster Victoza. An FDA advisory panel backed both drugs for approval last month, but Sanofi’s decision date is earlier than its rival’s, thanks to a priority review voucher the drugmaker bought from Retrophin for $245 million.
The first study, presented at the American Diabetes Association Scientific Sessions here on Sunday, LixiLan-O, tested the combo drug against both its ingredients, Lantus and Lyxumia (lixisenatide). LixiLan delivered A1C reductions of 1.6%, compared with 1.3% for Lantus alone and 0.9% for Lyxumia alone. And 74% of patients on the combo hit an A1C goal of less than 7%, while 59% of Lantus patients and 33% of Lyxumia patients hit that target.
The rate of hypoglycemia for LixiLan was similar to that of Lantus, though lower for patients on Lyxumia by itself. Other side effects included nausea and vomiting--which happened at a higher rate than in Lantus-only patients, but at lower rates than in the Lyxumia arms.
In the second trial, LixiLan-L, the combo beat Lantus by a smaller margin: It helped patients achieve a 1.1% reduction in A1C, versus 0.6% for Lantus. Slightly more than half of the LixiLan patients hit their A1C target of less than 7%, compared with 30% of patients using Lantus.
LixiLan patients suffered hypoglycemia at about the same rate as those on Lantus--40%, or 3 events per year, compared with 42.5% and 4.2 events--while more patients experienced nausea or vomiting with the combo drug.
Both studies enrolled patients unable to control their blood sugar on metformin or on metformin and an add-on drug. During the trials, patients continued their metformin treatment.
Berria said that the LixiLan combination will offer a new option for patients who haven't been able to control their blood glucose with other treatments. To add to its evidence, the company is planning a head-to-head trial of LixiLan in another group of patients: those who still struggle with their blood sugar levels even with treatment with a GLP-1.
The FDA is expected to give LixiLan a yea or nay in August, with a Xultophy decision on tap for September. The advisory committee backed LixiLan in a 12-2 vote; members raised questions about the pen injectors used to deliver the combo, but analysts didn’t consider those concerns severe enough to delay approval. Most of the committee members suggested the pen designs be modified, the analysts said after the panel meeting.
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Editor's note: This story was updated with comments from Dr. Berria, and to clarify that LixiLan was tested only in Type 2 diabetes.