- When the data on Lilly's lupus drug tabalumab was analyzed collectively, the determination was that it did not reflect significantly better outcomes than the current standard of care and as a result, the phase III trial has been abandoned.
- In one study, tabalumab did not achieve the primary endpoint of statistically significant improvement on the key measure of lupus disease activity and response, the SRI-5.
- When a higher dose of tabalumab was used, the outcomes were better and the primary endpoints were achieved in a phase III trial.
In testing tabalumab, Lilly conducted the largest phase III trials in lupus to date. Although they are not going to submit the data to the FDA and do not plan to move forward with development of tabalumab, Lilly is excited about the contribution of extensive data to the overall knowledge base for lupus.
Lilly has not had an easy time of it with this monoclonal antibody: In February 2013, tabalumab also failed in clinical trials for treatment of rheumatoid arthritis. For the latest failure, Lily will take a $75 million R&D charge in the third quarter.