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Lilly to Discontinue Development of Lupus Drug Tabalumab

Company cites ‘insufficient efficacy’ in phase III trials

Eli Lilly and Company has announced that it will discontinue development of tabalumab — being studied for the treatment of systemic lupus erythematosus (SLE) — because of insufficient efficacy in two pivotal phase III trials. The decision was not based on safety concerns.

Tabalumab, a biologic entity, is a fully human monoclonal antibody designed to have neutralizing activity against both membrane-bound and soluble B-cell activating factor (BAFF).

In the ILLUMINATE 1 study, tabalumab did not achieve the primary endpoint of a statistically significant improvement on the SLE Responder Index-5 (SRI-5), a measurement of lupus disease activity and response, compared with standard-of-care therapy. In the ILLUMINATE 2 trial, the higher dose of tabalumab met this endpoint. Collectively, the data from these studies did not meet expectations for efficacy in the context of existing treatments, the company says.

The overall safety profile showed a similar frequency of adverse events in patients treated with either tabalumab or standard of care.

Given the efficacy results from the two pivotal studies, Lilly will not move forward with submissions to global regulators.

SLE (also known as lupus) is a chronic autoimmune disease that can damage any part of the body (skin, joints, and/or organs inside the body), and that can range from mild to life-threatening. The Lupus Foundation of America estimates that up to 1.5 million people in the U.S. and 5 million people throughout the world have a form of SLE. It occurs mostly in women of childbearing age (15 to 44 years), although men, children, and teenagers can also develop the disease.

Source: Eli Lilly; October 2, 2014.

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