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Amylin Overshadowing Novo Nordisk's Victory


One diabetes drug gets approval, but another may quickly follow.

Novo Nordisk (NVO) has finally been victorious after 20 months of back-and-forth with the FDA concerning its type 2 diabetes treatment, Victoza.

The Danish drug giant received approval for Victoza, also known as liraglutide, late Monday night. "Novo Nordisk is committed to developing safe and effective drugs to treat diabetes, which is why the FDA approval of Victoza represents such an important milestone for the company and for people with type 2 diabetes," said Alan C. Moses, MD, chief global medical officer of Novo Nordisk.

While approval of the drug is a triumph for Novo Nordisk, that victory is bittersweet at best and may be a milestone for other companies as well.

(See, Biotech Drugs to Watch In 2010)

Victoza, a once-daily injectible, is the second drug to hit the market in a new class of diabetes drugs called GLP-1 analogs, which work like the naturally occurring GLP-1 compound in the body to slow glucose absorption in the gut and thus allow a type 2 diabetic's slow insulin response to catch up. Unlike the naturally occurring compound, the agonists aren't easily broken down by the body's enzymes. The GLP-1 agonist class also attaches to an appetite receptor in the brain and decreases hunger, leading to weight loss in patients.

The first GLP-1 drug on the market is Amylin Pharmaceuticals (AMLN) and Eli Lilly's (LLY) Byetta, which garnered FDA approval in 2005. The class of drugs has been seen as one of the most promising types of new treatment areas for diabetics, but it has seen its share of problems as well.

The twice-daily injectible has been a blessing for the millions of patients who currently take the drug, but Byetta came under fire in August 2008 when the FDA announced that six patients who had been taking the drug had developed severe pancreatitis. The condition can release toxins into the bloodstream and has been known to develop in patients with diabetes. Each of the six patients required hospitalization, and two died. Several other cases linking pancreatitis to Byetta cropped up in the months following. The companies are currently tied up in 39 separate liability cases concerning the drug.

But Byetta never fully recovered and only pulls in about $675 million annually in revenues. Byetta's poor performance has left the door open for other drugs that are safer and more convenient to take over market share.
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