|
 The USA Food and Drug Administration ( FDA) has delayed approval of a once-per-week version of the diabetes drug Byetta.
According to a Reuters report, the FDA has requested additional information and quality assurances from the companies bringing the drug to market - Amylin and Eli Lilly.
Because the request is for information and not for additional clinical trials, analysts believe that the drug, whose proposed name is Bydureon, will be approved later this year.
Bydureon (whose chemical name is exenatide LAR), is a member of a class of medications which lower blood glucose levels by increasing the body’s production of insulin.
The FDA approved drugs in this class are Byetta which is a twice-per-day injection, and the recently approved Victoza which is a once-per-day injection. Victoza carries a warning for the risk of thyroid cancer, and Byetta has been associated with a risk of pancreatitis.
Why is this important?
Byetta is currently available in Australia, while Victoza and Bydureon have not yet been approved by Australia’s Therapeutic Drugs Administration ( TGA).
As Bydureon requires only one injection per week, it will be much more appealing than a once or twice-daily injection.
Story Links
Reuters Report http://www.reuters.com/article/idUSTRE62E1YU20100315?type=globalMarketsNews
 |
