Lilly Discontinues Development of Phase III Lupus Drug

Eli Lilly and Co. is discontinuing development of tabalumab being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus), due to insufficient efficacy in two Phase III trials. The decision was not based on safety concerns.
 
In the ILLUMINATE 1 study, tabalumab did not achieve the primary endpoint, at either dose studied, of statistically significant improvement of lupus disease activity compared to standard of care therapy. In ILLUMINATE 2, the higher dose of tabalumab met this endpoint, but collectively, the data from these studies did not meet expectations for efficacy compared to existing treatments. The overall safety profile showed similar adverse events in patients treated with either tabalumab or standard of care.
 
The decision to discontinue development of tabalumab for lupus is expected to result in a third-quarter R&D charge of as much as $75 million.
 
“Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in one of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies,” said J. Anthony Ware, M.D., senior vice president, product development, Lilly Bio-Medicines. “Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus.”