Lilly’s Hopes For Tabalumab Now Rest In Lupus, Myeloma Settings
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The company terminates all late-stage development of the anti-B cell antibody in rheumatoid arthritis due to lack of efficacy. Ongoing studies in lupus and multiple myeloma are expected to begin reporting in 2014.
You may also be interested in...
Lilly Puts Faith In Late-Stage Assets In Hopes Of Profit Growth In 2014
Lilly is making major bets on the oncology and diabetes drugs in its late-stage pipeline in hopes that these assets will fill the hole left by Zyprexa, and soon Cymbalta.
Lilly Antibody Proves Ineffective In Rheumatoid Arthritis, But Lupus Trials Continue
Lilly has stopped one Phase III rheumatoid arthritis trial for its anti-BAFF antibody tabalumab and ceased enrollment in two others after a mid-term analysis revealed a lack of efficacy, but the company is soldiering on with a Phase III program in lupus erythematosus.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.