Advisory Committee Recommends Approval for Prandin, Novo Nordisk's New Oral Hypoglycemic Agent.PRINCETON, NJ--(BUSINESS WIRE)--Nov. 19, 1997--Novo Nordisk A/S (NYSE NYSE See: New York Stock Exchange :NVO NVO no visible oestrus (see no visible estrus). Called also NVE. ) said it is pleased by today's U.S. Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Endocrinologic and Metabolic Drugs Advisory Committee recommendation for approval of Prandin(TM)(repaglinide repaglinide /re·pag·li·nide/ (re-pag´li-nid) an oral hypoglycemic agent used in the treatment of type 2 diabetes mellitus. repaglinide Warning - High-alert drug! ). Lars Rebien Sorensen, Corporate Executive Vice President, head of Health Care at Novo Nordisk said, "With our focus on Diabetes Care as one of our core business areas, Novo Nordisk considers Prandin(TM) a product of strategic importance, offering people with Type 2 diabetes type 2 diabetes n. See diabetes mellitus. a product with therapeutic advantages over currently available oral anti-diabetic agents." The Advisory Committee reached its decision after reviewing clinical trials in over 2200 patients with Type 2 diabetes. These studies showed that when Prandin(TM) is taken with meals it restores the post meal glucose curve towards that seen in healthy individuals. Prandin(TM) has a rapid onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. , is quickly removed from the bloodstream and is therefore dosed prandially. Prandin(TM) is a new chemical entity for oral treatment of Type 2 diabetes designed to regulate meal related glucose loads. Prandin(TM) received expedited review status by the FDA in August, significantly reducing the anticipated standard review time for a new product. This classification is neither an assurance of an FDA decision by the end of the year or a guarantee of approval. The trade name for repaglinide outside of the U.S. is NovoNorm(R). Repaglinide was developed in cooperation with the German pharmaceutical company Boehringer Ingelheim. The product was in-licensed by Novo Nordisk for worldwide marketing. Novo Nordisk A/S is the world leader in insulin and diabetes care and also manufactures and markets a variety of other pharmaceutical products. Furthermore the company is the world's largest producer of industrial enzymes. Headquartered in Denmark, Novo Nordisk employs approximately 13,900 people in 61 countries and markets its products in 130 countries. Its B shares are listed on the stock exchanges in Copenhagen, London and Zurich. Its ADSs are listed on the New York Stock Exchange New York Stock Exchange (NYSE) World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. under the symbol "NVO." CONTACT: Novo Nordisk Media: Investors: Susan Toth Jackson Peter Baekgaard Tel: 212/867-0123 Tel: 212/867-0123 Fax: 212/986-6499 Fax: 212/867-0298 |
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