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7. Diabetes drug updates
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| Next Once-Daily GLP-1 Agonist, Lixisenatide, Approved in EU |
 The European Commission has granted approval of lixisenatide (Lyxumia, Sanofi) for the treatment of adults with type 2 diabetes. The drug, a once-daily glucagon-like peptide 1 (GLP-1) agonist, is indicated to achieve glycemic control in combination with oral glucose-lowering products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.
Lixisenatide was approved in its first market, Mexico, last month, and Sanofi expects to file for US approval of lixisenatide in the first quarter of this year. Sanofi licensed rights to the product from Denmark's Zealand Pharma.
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| Degludec (Tresiba) F.D.A. approval delayed |
FDA delayed approval of new long-acting insulin Tresiba demanding that it conduct additional clinical tests to assess potential heart risks. Food and Drug Administration had requested additional data from a dedicated cardiovascular outcomes trial before it would consider approving Tresiba and a related product, Ryzodeg. Analysts said the F.D.A.’s stance could delay Tresiba until 2015 or 2016.
Optimism about Tresiba and Ryzodeg — which combines degludec with another formulation of insulin — was further bolstered by final approval in Europe last month. They have also been approved in Japan. The F.D.A. advisers meeting last year expressed concern about a trend toward higher incidence of adverse heart events with the new insulin than with older types. The differences seen in 16 large clinical trials, however, were not statistically significant. |
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| FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes |
Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.NESINA is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). OSENI, which combines alogliptin with pioglitazone, is the first product in the U.S. to include both a DPP-4i and a thiazolidinedione (TZD) in a single tablet. KAZANO combines alogliptin with metformin HCl, a widely used anti-diabetes medication, in a single tablet. |
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