Amylin and Eli Lilly Seek Approval of Long-Acting Version of Byetta
December 16, 2008
Amylin Pharmaceuticals Inc., Eli Lilly and Co., and Alkermes Inc. are developing a long-acting release (“LAR”) version of the diabetes drug Byetta (exenatide). First introduced by Amylin and Eli Lilly in 2005, Byetta is an injectable drug used in the treatment of type 2 diabetes that must be taken twice a day. The Byetta LAR, however, can be taken once a week. In a statement released by Amylin, the company announced that the U.S. Food and Drug Administration (“FDA”) will accept data from an ongoing clinical study of Byetta LAR instead of requiring a new study. Further, the companies expect to seek FDA approval of the drug during the first half of 2009.
In November 2008, FDA concerns arose over Byetta LAR during a major clinical trial. The FDA noted that batches of the drug produced in the Alkermes manufacturing facility were different than batches of the drug produced at the Amylin’s manufacturing facility. The FDA’s concerns have since been resolved.
Still, medical concerns exist over use of Byetta. In October 2007, the FDA noted 30 reports of acute pancreatitis (inflammation of the pancreas). Following this occurrence, the FDA asked the Byetta manufacturers, Amylin and Eli Lilly, to include information on acute pancreatitis. On August 18, 2008, the FDA announced it planned to strengthen warnings linking Byetta to life-threatening pancreas problems following reports of hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) and necrotizing pancreatitis (wherein an inflamed pancreas destroys itself).
An individual using this drug should notify their doctor immediately if they suffer symptoms relating to acute pancreatitis. The most common symptom of pancreatitis is severe pain in the upper stomach spreading to the back. The pain may begin or worsen after eating, last a few days, and may worsen when a person lies on his or her back. Along with severe pain, acute pancreatitis sufferers also experience:
- Nausea (and, sometimes, vomiting)
- Fever, chills, or both
- Swollen abdomen which may be tender when touched
- Rapid heartbeat
The FDA noted that Byetta injections should be discontinued if pancreatitis is suspected.
If you or a loved one has suffered from any health effects because of taking Byetta, contact us today for a confidential and free Byetta lawsuit evaluation.