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Eli Lilly: Development of Lupus Drug is Halted
- Updated: October 3, 2014
Eli Lilly and Company, one of the top drug makers, released a statement that the development of a drug called tabalumab intended to treat patients with lupus is being stopped, this after two trials showed insufficient efficacy.
During the ILLUMINATE 1 study of tabalumab, the primary endpoint at both doses studied failed to show statistically significant improvement on SRI-5, which is designed to measure the activity of lupus. In comparison, the endpoint of the drug was reached during the ILLUMINATE 2 study but at a higher dose.
Data gathered from both studies did not meet efficacy expectations in the framework for existing treatments.
The safety profile used during the two studies is similar to current standard care options. However, based on the outcome, researchers are halting work on the development of tabalumab, to include seeking approval from the US Food and Drug Administration (FDA), as well as other global regulatory entities.
According to Dr. Anthony Ware, Senior Vice President of Product Development for Eli Lilly and Company BioMedicines, while researchers are thrilled that tabalumab met set criteria for statistically significant improvement in the SRI-5 endpoint during the second trial, there is great disappointment that overall results were unable to provide meaningful improvement for patients with lupus.
Lupus, which affects roughly 1.5 million people in the United States, is a chronic autoimmune disease that can cause damage to virtually any part of the body although joints, internal organs, and skin are most commonly affected. Normally, the body’s immune system works to fight off bacteria, viruses, and germs through naturally produced proteins known as antibodies.
In the case of lupus, the immune system cannot differentiate between foreign invaders and healthy tissue. As a result, autoantibodies are created that attack and destroy healthy tissue, leading to substantial pain, inflammation, and damage.
Dr. Ware adds that even though the development of tabalumab is being stopped, Eli Lilly and Company is dedicated to developing other new medicines to treat autoimmune disorders to include lupus.