Diabetes Time-Released Weekly Byetta on Track
Eli Lilly and Company Expects to Seek Approval in Early 2009
Dec 11, 2008
Diabetics who are used to injecting drugs twice a day to control the disease may soon be able to use a one-time-released drug weekly. At present, it is used most often to treat patients who no longer respond adequately to oral diabetes drugs. Eli Lilly and Company announced on December 11, 2008 that it will apply for further approval in 2009 from the Federal Drug Administration (FDA) which has been held back by reports of pancreatitis.
Byetta and Past History
Byetta is usually prescribed for patients who no longer respond to other drugs. Concerns about a rare but potentially deadly pancreatic condition linked to its use led federal regulators to strengthen warnings about the drug. There are also side effects including nausea and vomiting.
Byetta Positive Clinical Trials
In a new study, funded by Lilly and Amylin Pharmaceuticals Inc, the other manufacture involved with the development of Byetta, 259 patients with type 2 diabetes were treated with either the once-a-week, long-acting form of the drug or the twice daily version for 30 weeks. Most of the patients in both groups saw significant improvement in the glucose control measure known as hemoglobin A lc. All subjects in the study had an entry level of 8.3%. The results showed that:
- Once-weekly formulations levels fell to 6.5%
- Twice-a-day formulations levels fell to 6.8%
The hemoglobin A lc goal for diabetics is less than 7 percent.
Results and Side Effects
Reduction in weight were experienced by both groups. In addition, nine patients receiving the once-a-week Byetta and eight patients in the twice daily drug withdrew because of side effects. However, according to the study, those taking Byetta had less nausea and vomiting.
Accompanying the study was an editorial by Andre J. Scheen, MD, PhD of Belgium's University of Liege, who wrote that the better blood sugar control and reduced amount of nausea seen with the once-weekly injection make the experimental formulation a highly promising diabetes treatment. Dr. Scheen added that "When the once-a-week formulation becomes available, after confirmation and extension of the study's positive results, this new strategy might substantially change the management of type 2 diabetes."
The Future of Byetta
As stated in the Guardian ( 12/11/08), Eli Lilly and Co. expects to seek approval by the first half of 2009 for it once-weekly version of the diabetes drug Byetta, which is now injected twice a day. For those suffering from the disease, its progress will be watched eagerly. For Lilly, if approved by the FDA, it would help fulfill its prediction of increased earning of 15% in 2009.
The hope for a weekly diabetes drug continues, in spite of the pancreatitis problems with Byetta, including some deaths associated with the drug. Patients and their physicians should work together in determining whether it is the right drug for them.
Source: WebMD Health News
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