On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the United States, as well as a marketing authorization application to the European Medicines Agency in Europe, for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 14, 2008.
About LEAD(TM) (Liraglutide Effect and Action in Diabetes)
LEAD(TM) (Liraglutide Effect and Action in Diabetes) 6 is the first trial to be reported from the phase 3b LEAD(TM) program. Topline results from the LEAD(TM) 6 study were released by Novo Nordisk in a Stock Exchange Announcement on June 6, 2008.
The phase 3a LEAD(TM) program, which comprised the regulatory filing documentation for liraglutide, included trials 1-5. The purpose of the LEAD(TM) program is to compare liraglutide directly against commonly used therapies in type 2 diabetes, except for metformin, with which it is used in combination.
Novo Nordisk is a healthcare company and a world leader in diabetes
care. In addition, Novo Nordisk has a leading position within areas such as
hemostasis management, growth hormone therapy and hormone replacement
therapy. Novo Nordisk manufactures and markets pharmaceutical products and
services that make a significant difference to patients, the medical
profession and society. With headquarters in Denmark, Novo Nordisk employs
approximately 26,550 employees in 80 countries, and markets its products in
179 countries. Novo Nordisk's B shares are listed on the stock exchanges in
Copenhagen and London. Its ADRs are listed on the New York Stock Exchange
under the symbol 'NVO'. For more information, visi
|SOURCE Novo Nordisk|
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