International Approvals: Januvia, Synvisc-One, Eloxatin

Yael Waknine

January 29, 2008

January 29, 2008 — The European Commission (EC) has approved sitagliptin tablets for use as add-on therapy to a sulfonylurea both with and without metformin in type 2 diabetic patients who require improved glycemic control and has approved a single-treatment formulation of hylan G-F 20 that provides 6 months of pain relief from osteoarthritis of the knee. Health Canada has approved oxaliplatin intravenous infusion for use with fluorouracil and leucovorin in the adjuvant treatment of stage 3 colon cancer.

Additional Indications for Sitagliptin Tablets (Januvia) in EU

On January 21, the European Commission approved 2 new indications for sitagliptin tablets (Januvia, Merck Sharp & Dohme), allowing their use with diet and exercise as add-on therapy with a sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control and as add-on therapy to glimepiride and metformin when dual therapy does not achieve adequate control in patients with type 2 diabetes.

"The approval of these new indications is another step forward in helping to combat type 2 diabetes. It is important because it provides physicians and patients with more options to achieve reduced glycemic levels," states Stefan Oschmann, president of Europe, Middle East, Africa, and Canada, Merck & Company, Inc, in a company news release.

Use of sitagliptin and a sulfonylurea (glimepiride) with or without metformin is supported by data from a randomized, double-blind, placebo-controlled study (N = 441), showing that the addition of sitagliptin to glimepiride/metformin therapy or metformin alone achieved significantly greater decreases from baseline A1C (7.5% – 10.5%) at 24 weeks (0.9% and 0.6%; P < .001 for both vs placebo).

Patients in this study receiving sitagliptin experienced an increased rate of adverse events, including hypoglycemia (12.2% vs 1.8% for placebo), which often occurs when antihyperglycemic agents are used in combination with sulfonylureas. A lower dose of the sulfonylurea may be required to reduce this risk.

Sitagliptin was previously approved for these indications by the US Food and Drug Administration on October 12, 2007. The agent previously was approved by the EC for use with metformin (or in certain patients, a thiazolidinedione) when diet and exercise plus either agent do not provide sufficient glycemic control.

Single-Treatment Formulation of Hylan G-F 20 (Synvisc-One) in EU

On December 19, the European Commission granted a CE mark for a single-treatment formulation of hylan G-F 20 (Synvisc-One, Genzyme Biosurgery [Genzyme Corp]) that provides up to 6 months of pain relief from osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics.

In contrast with the current product that is administered via three 2-mL intra-articular injections at 1-week intervals, the new formulation combines the 3 doses into one 6-mL injection.

"Delivering the benefits of Synvisc through 1 treatment rather than 3 will provide additional options for physicians and their patients to reduce the cost and burden of multiple injections," says Ann Merrifield, president of Genzyme Biosurgery, in a company news release.

The approval was based on data from a double-blind study (N = 253) that demonstrated a statistically significant improvement in pain over 26 weeks for patients receiving hylan G-F vs placebo. Patient and physician global assessments likewise showed significant benefit, and safety profiles were no different from that of placebo.

The 6-mL formulation of the drug has not been approved by the US Food and Drug Administration.

Oxaliplatin Infusion (Eloxatin) for Stage 3 Colon Cancer in Canada

On December 18, Health Canada approved oxaliplatin intravenous infusion (Eloxatin, sanofi-aventis Canada, Inc) for use in combination with infusional 5-fluorouracil and leucovorin in the adjuvant treatment of stage 3 (Duke's C) colon cancer after complete resection of the primary tumor.

Approval of the agent was based on the phase 3 results of the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin (5-FU/LV) in the Adjuvant Treatment of Colon Cancer trial, showing that the addition of oxaliplatin to 5-FU/LV significantly increased disease-free survival at 3 years compared with 5-FU/LV alone (72.2% vs. 65.3%; 24% decrease in risk of recurrence) in patients with completely resected stage III colon cancer.

"The approval of Eloxatin for use after surgery provides my patients with the hope that they can better their chances of being cancer free," said Yoo-Joung Ko, MD, a Toronto-based oncologist. "The safety and efficacy profile of Eloxatin is clinically superior to the previous standard treatment, making this an important advancement in the treatment of the disease."

Combination therapy with oxaliplatin plus 5-FU/LV was well tolerated, with neutropenia being the most frequently reported adverse effect, and was complicated by fever or infection in 1.8% of cases. Patients experiencing peripheral sensory neuropathy showed total or partial recovery within 6 months after treatment.

Oxaliplatin was previously approved for this indication by the European Commission and US Food and Drug Administration.

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