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Jul 12, 2010
 |  BioCentury  |  Regulation

Changing NICE's Mind

How Novo Nordisk changed NICE view on Victoza in diabetes

In February, the U.K.'s NICE issued a preliminary appraisal relegating Novo Nordisk A/S's Victoza liraglutide to use as a third-line option in triple therapy regimens for Type II diabetes. But the company pressed forward with new data showing improvement in weight loss and glucose control in patients with a higher body mass index, which now has convinced the agency that Victoza warrants coverage as second-line treatment despite a higher cost per QALY.

Based on the second preliminary appraisal released by NICE last month, the 1.2 mg dose of Victoza now is recommended both as a dual therapy in second-line regimens in combination with metformin or a sulfonylurea in a subgroup of patients intolerant to other second-line drugs, and as part of third-line triple therapy in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione (TZD).

Novo had hoped to get a recommendation for broad second-line use. But while the company didn't get everything it asked for, the decision does put Victoza ahead of Byetta exenatide from Amylin Pharmaceuticals Inc. and Eli Lilly and Co. While both glucagon-like peptide-1 (GLP-1) analogs are labeled in the U.K. for second- and third-line use, NICE recommends Byetta only as a third-line option in patients with BMI >=35 kg/m2.

First try

In October 2009, Novo submitted data from six trials to NICE to support the use of Victoza as a second- and third-line treatment option for Type II diabetes. Three trials were to support the use of Victoza as part of dual second-line therapy and three to support use as part of triple third-line therapy, including the LEAD-6 trial vs. Byetta.

The 26-week, double-blind Phase III LEAD-6 study showed that Victoza plus metformin and/or sulfonylurea reduced HbA1c more than Byetta.

In the 464-patient study, 1.8 mg of once-daily Victoza reduced HbA1c by 1.1% from baseline vs. 0.8% for Byetta (95% CI: -0.47, -0.18; p<0.0001).

Both drugs also showed a reduction in weight, but the difference between the two treatments was not statistically significant.

While Victoza outperformed Byetta in LEAD-6, NICE's February recommendation confined Victoza to the same third-line use as the agency had for Byetta: patients who have a BMI >=35 kg/m2.

Nor was NICE convinced by Novo's Phase III trials of Victoza as second-line dual therapy: LEAD-1, LEAD-4 and Study 1860.

In LEAD-1, 1.2 mg Victoza plus a sulfonylurea resulted in an HbA1c reduction of 1.08% vs. 0.44% for Avandia rosiglitazone (p<0.0001). Based on the analysis,...

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