Novo Nordisk Pharma Applies For Approval For Diabetes Drug Liraglutide
This article was originally published in PharmAsia News
Executive Summary
Tokyo based Novo Nordisk Pharma applied for approval for liraglutide, a once-daily human GLP-1 analog for the treatment of type 2 diabetes. In Phase 3 domestic clinical trials in Japan, liraglutide was shown to significantly reduce HbA1c level after 24 weeks of administrating of either the drug alone or combined with sulfonylureas. When combined with sulfonylureas, about half of the patients had their HbA1c level reduced below 6.5 percent. The treatment did not run a risk of inducing hypoglycaemia. Novo Nordisk applied for approval for liraglutide with U.S. FDA and EMEA on May 23. (Click here for more - Japanese language
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Tokyo based Novo Nordisk Pharma applied for approval for liraglutide, a once-daily human GLP-1 analog for the treatment of type 2 diabetes. In Phase 3 domestic clinical trials in Japan, liraglutide was shown to significantly reduce HbA1c level after 24 weeks of administrating of either the drug alone or combined with sulfonylureas. When combined with sulfonylureas, about half of the patients had their HbA1c level reduced below 6.5 percent. The treatment did not run a risk of inducing hypoglycaemia. Novo Nordisk applied for approval for liraglutide with U.S. FDA and EMEA on May 23. (Click here for more - Japanese language) "Novo Nordisk Applies Approval For Human GLP-1 Receptor Agonist, The First In Japan" - Yakuji News (7/16/08) |