Almost Here: Byetta
One of the hardest things about living with diabetes is the challenge of controlling blood sugar levels on a daily basis. While oral medications have broken on to the scene, insulin shots are by far the most common treatment prescribed for diabetes patients. These daily or several times daily injections make life painful and labor-intensive for most diabetics. But drug companies like Amylin Pharmaceuticals and Novo-Nordisk are hard at work creating new diabetes treatments that can last longer—maybe even as long as a week!
The U.S. Food and Drug Administration (FDA) has just given its stamp of approval to one such treatment: Victoza, produced by Novo-Nordisk. While this diabetes treatment comes with some risks, its availability helps other drug companies, for instance Amylin, promote their own novel diabetes treatments.
The newest drug produced by Amylin Pharmaceuticals is exenatide. This drug, which will be manufactured as Byetta, will only need to be administered once a week. President and CEO of Amylin, Ginger Graham comments, "This is an important step in the regulatory process as we work to transition exenatide from an investigational agent to the marketplace; providing an additional therapy to people living with type 2 diabetes."
It is believed that the approval of Victoza, and hopefully Byetta, will have competing drug companies racing to create similar medications. Millions of Americans suffer from diabetes, so the companies stand to profit big-time from these long-term treatments for the big "D." One Citi research analyst announced that Amylin's shares rose from $14 to $27 after Victoza received approval. A Barclays' analyst said that this raised the target price from $22 to $24.
It is expected that Byetta will complete its FDA review by early March 2010. While clinical trials have shown the drug to have impressive results, side effects, for instance inflammation of the pancreas, are still major concerns. Byetta may also pose a risk by causing blood sugar levels to become too low. Victoza had similar birth pangs since it works by the same mechanisms. These drugs consist of an injected hormone known as GLP-1 that causes the pancreas to manufacture more insulin after food intake.
Researchers in the UK have been asked to issue new diabetes treatment guidelines, since one major study showed that a target blood glucose level of 7.5% is safer than 7% in those who suffer from hypoglycemia as opposed to hyperglycemia.