Janssen discontinues fulranumab phase 3 development program in osteoarthritis pain

The company said its decision was not based on any emerging safety concerns from the phase 3 clinical trials with fulranumab.

Janssen Pharmaceuticals is terminating its licensing deal with Amgen for fulranumab. The entire program rights are being returned back to Amgen.

Amgen licensed fulranumab, an anti-nerve growth factor (NGF) monoclonal antibody, to Ortho-McNeil-Janssen Pharmaceuticals (now Janssen Pharmaceuticals) in 2008.

The neuroscience therapeutic area of Janssen Research & Development will continue its discovery and development programs in Alzheimer’s and severe mental illness.

The US Food and Drug Administration placed a hold on the development of anti-NGFs in April 2011 over safety concerns. However, the hold was later lifted.

In an other development, Janssen Research & Development unveiled positive results of a pre-planned interim analysis of the phase 3 MMY3004 (CASTOR) trial evaluating the efficacy and safety of daratumumab in combination with bortezomib and dexamethasone, compared to bortezomib and dexamethasone alone, in patients with relapsed or refractory multiple myeloma.

The interim analysis, undertaken by an Independent Data Monitoring Committee (IDMC), identified that the daratumumab combination treatment regimen improved progression-free survival (PFS) compared with bortezomib and dexamethasone alone, achieving the primary study endpoint (p < 0.0001).

Darzalex (daratumumab) injection for intravenous use is claimed to be the first CD38-directed monoclonal antibody (mAb) approved anywhere in the world.

CD38 is a surface protein that is highly experienced across multiple myeloma cells, regardless of disease stage.