Federal drug regulators have approved a new weekly incretin mimetic diabetes injection, which works similar to the existing drugs Byetta and Victoza. However, the medication will be introduced with a black box warning about the potential risk of thyroid cancer, and comes amid continuing concerns about the potential risk of pancreatic cancer associated with the entire class of diabetes drugs.
Eli Lilly’s Trulicity (dulaglutide) was approved by the FDA on September 18, as a weekly subcutaneous injection designed to help diabetics control blood sugar levels.
It is part of a class of medications known as incretin mimetics, which also include the blockbuster diabetes injections Byetta and Victoza, as well as popular oral versions like Januvia and Janumet.
The approval comes after only six clinical trials involving just 3,342 patients, and as many experts question the safety of incretin mimetics and whether the potential risk of pancreatic cancer and severe pancreatitis outweigh the benefits provided over other available diabetes treatments.
Trulicity will carry a black box warning at the time it is introduced, which is the strongest warning the FDA can require for a prescription medication, indicating that use of the medication may be linked to the development of thyroid c-cell tumors.
The agency also only agreed to release the drug with a Risk Evaluation and Mitigation Strategy (REMS), which involves a communication plan to ensure that doctors are fully informed about the risk of Trulicity side effects.
FDA officials determined that approval of the medication was justified, due to the diabetes epidemic in the U.S.
Eli Lilly will be required to conduct a number of post-marketing studies to be conducted, including tests for cardiovascular risks, a pediatric safety study, a thyroid cancer study, a study on reproductive side effects and a study involving patients with kidney problems.
Diabetes Drug Cancer Lawsuits
Trulicity will be introduced as a growing number of Byetta lawsuits, Victoza lawsuits, Januvia lawsuits and Janumet lawsuits continue to be filed against the makers of the other members of this same class of medications.
In the federal court system, more than 500 cases filed on behalf of individuals nationwide diagnosed with pancreatic cancer after using the medications are consolidated as part of an incretin mimetic diabetes drug litigation, which is centralized for pretrial proceedings before U.S. District Judge Anthony Battaglia in the Southern District of California as part of an MDL, or multidistrict litigation.
Incretin mimetics work by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin following a meal.
Side effects of the diabetes drugs have previously been linked to a risk of severe pancreatitis, which some reports suggest may lead to the development of pancreatic cancer for some users.
As part of the coordinated pretrial proceedings before Judge Battaglia, it is expected that a series of early trial dates will be scheduled in the MDL involving each of the different medications, to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes are not binding in other cases, it may help the parties reach additional agreements to settle Byetta and Januvia cases.
On September 16, parties involved in the cases participated in a telephone case management conference to discuss moving the cases forward toward resolution. The next status conference is scheduled for October 9, and
The parties are dealing with a number of disputes over the discovery process, where both sides turn over documents and interview witnesses relevant to the claims and allegations. The next status conference is scheduled for October 9, and it is possible that the first trial dates may begin in late 2015.