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Should FDA Really Approve Byetta LAR?


Sales of drug have been bogged down by problems since reports in 2008 that it could cause severe side effects.

After being put off one week for weather-related reasons, the FDA is finally going to make a decision on Friday about Amylin Pharmaceuticals (AMLN) and Eli Lilly's (LLY) long-acting release diabetes drug Byetta LAR.

All signs point to approval.

Yet, patients (and investors) should be wondering if approval of such a drug is really the responsible decision. Sure, investors have been betting that Byetta LAR will get approved for some time now, and many are hoping for a nice bump in the stock price when it happens. But from a regulatory perspective, it might not be a great idea.

(See Biotech Drugs to Watch in 2010.)

The original formulation of Byetta, a twice-daily injection, has been on the market since 2005 and has helped millions of type-2 diabetes sufferers control their blood sugar; it was the first of its class in diabetes drugs. (A second drug of the same class by Novo Nordisk (NVO) was approved earlier this year.) The drugs, called GLP-1 agonists, 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.

Yet, weight loss isn't the only side effect of the GLP-1 agonists. Byetta sales have been bogged down by problems since reports surfaced in August 2008 that the drug could be the cause of severe pancreatitis, a disease that occasionally develops in diabetic patients anyway. Several Byetta patients that developed pancreatitis died, and cases continue to pop up. The companies are currently tied up in 39 separate liability cases concerning the drug.

While pancreatitis is the biggest drawback to these types of drugs, it isn't the only one. In 2009, the FDA notified health-care professionals that Byetta had been causing kidney problems, including renal failure. Between April 2005 and October 2008, the agency had received 62 cases of acute renal failure and 16 cases of renal insufficiency, prompting more patients to try other forms of diabetes treatments.

Novo Nordisk's Victoza, a once-daily injection that was recently approved by the FDA, was slapped with a black-box warning -- the severest the FDA offers. However the warning wasn't about the potential kidney problems or pancreatitis that could occur, but to caution that the drug could cause thyroid tumors.

The long-acting version of Byetta is expected to be plagued by all the same problems, but it will be in a patient's system for a full week -- a lengthy amount of time, should problems arise. The FDA is aware of the risk and it will be the agency's job to weigh that against the potential benefit. But will patients really prefer the convenience when there are so many other options out there?
No positions in stocks mentioned.

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