Onglyza saxagliptin regulatory update

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that Onglyza saxagliptin from AstraZeneca and Bristol-Myers has "marginal" additional benefit to treat Type II diabetes in combination with metformin vs. metformin and sulfonylurea. G-BA did say that Komboglyze has "no additional benefit" in combination with sulfonylurea vs. human insulin and sulfonylurea; in combination with metformin and sulfonylurea vs. human insulin and metformin; and in combination with insulin with or without metformin vs. human insulin and metformin. In a July preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said the drug has "no additional benefit" (see BioCentury, July 15).

Onglyza and 4 other dipeptidyl peptidase-4 (DPP-4) inhibitors are the first group of drugs being assessed under drug pricing law AMNOG that were launched in Germany before the law came into effect in January 2011. In August, the European Commission approved Onglyza as monotherapy to treat Type II diabetes. G-BA said that an assessment of the indication is ongoing; the preliminary assessment is expected in early December. The drug is also approved in the EU as combination therapy with insulin, with or without metformin, and in dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione, and triple oral therapy in combination with metformin plus a sulphonylurea. ...