Lilly To Record Charge In Q3 As It Discontinue Development Of Tabalumab

(RTTNews) - Drugmaker Eli Lilly and Co. (LLY) on Thursday said it will drop the development of tabalumab, as the results from its two pivotal Phase 3 trials did not meet expectations for efficacy in the context of existing treatments. The decision will result in a pre-tax charge of $75 million or $0.04 to $0.05 per share in the third quarter.

Tabalumab was being evaluated in the trial for the treatment of systemic lupus erythematosus or SLE, commonly known as lupus. In the Illuminate 1 study, tabalumab did not meet the primary endpoint, at either dose studied, of statistically significant improvement on SRI-5, compared to standard of care therapy. In Illuminate 2, the higher dose of tabalumab met this endpoint. But collectively, the data from these studies showed insufficient efficacy and the overall safety profile showed a similar frequency of adverse events in patients treated with either tabalumab or standard of care.

In the light of these negative results, Lilly said it will not move forward with submissions to global regulators.