Byetta (Exenatide) is an injectable subcutaneous anti-diabetic drug belonging to the class incretin mimetics, manufactured by San Diego-based Amylin Pharmaceuticals/Eli Lilly & Co. and distributed by AstraZeneca Pharmaceuticals LP. Byetta is similar to Januvia, Janumet, and Victoza. All the four drugs are classified as Incretin Mimetics and used to treat Type 2 Diabetes Mellitus. It is a glucagon-like peptide-1 (GLP-1) receptor agonist used as an adjunct to diet and exercise program, to improve the glycemic control in adult patients with Type 2 diabetes mellitus.
Bristol-Myers Squibb, one of the world's largest pharmaceutical companies, bought Byetta for an estimated $5.3 billion in 2012.
The drug was approved by the U.S. Food and Drug Administration (FDA) on April 28th, 2005. On 2nd November 2009, it was approved for the expanded use as a First-line treatment for Type 2 Diabetes. On 20th October 2011, it was approved for use with Insulin Glargine in the U.S.
In January 2012, Bydureon, a once-weekly injection was finally approved by the FDA, which was rejected twice earlier in 2010 because of heart rhythm abnormalities. (Bydureon is a longer-lasting version of Byetta.)
When Byetta was introduced in the year 2005, it was unique and different from other drugs. Hundred of patients who used it for Type-2 diabetes till now have experienced pancreatitis side effects or been diagnosed with pancreatic cancer. Some of them even have died due to the complication related to this drug. Unknown side effects of Byetta have been hidden from the public, which resulted in the filing of lawsuits against the manufacturer of this drug. Approximately 1000 cases against Byetta are currently pending trials in a federal court in California.
In the year 2005, makers of Byetta, Amylin Pharmaceuticals, and Eli Lilly and Company announced that the drug for controlling blood sugar in Type 2 diabetes was approved by FDA.
During the press release in the year 2005, the CEO of Eli Lilly and Company stated that Byetta has special content and design which can provide a new option for Type 2 diabetes patients and the launch of the drug in the market is a big milestone in itself.
Bristol-Myers Squibb and AstraZeneca were tempted to acquire Amylin Pharmaceuticals for around $7 B. AstraZeneca later purchased the diabetes division of Bristol-Myers Squibb’s that includes Byetta for more than $4 billion. By the year 2012, Byetta earned billion by its sale. Physicians and patients found this drug at that time a new weapon to fight the diabetes epidemic.
As per lawsuits filed, plaintiffs claim that manufacturers of Byetta did not perform the safety test to check the side effects of the drug, before seeking approval for its sale. Later on when makers of Byetta came to know about the shortcoming of their drug. They failed to warn about the risk to doctors as well as patients.
The German Medical Association in its study has stated that a higher rate of pancreatic cancer was observed in patients intaking Byetta. A clear linkage was shown between exenatide, an active ingredient in Byetta with the development of pancreatic cancer.
By the year 2013, dozens of pancreatic cancer lawsuits against manufacturers of Byetta were filed together in the Southern District of California as multidistrict litigation (MDL). Within two years the lawsuits in the MDL swelled into hundreds. The plaintiffs have various allegations like Byetta manufacturers did not mention the risk in their warning label, the defective design are unreasonably dangerous and most importantly the makers of this Type-2 diabetes drug allegedly kept the fact about the risk of pancreatic cancer development hidden from the public.