Novartis and Novo Nordisk report major cardiovascular drug trial failures

Novartis and Novo Nordisk have reported significant setbacks in their cardiovascular drug development programs following the failure of two major Phase 3 clinical trials.

Novartis announced that its drug pelacarsen, developed with Ionis Pharmaceuticals, failed to meet its primary goal in the Lp(a)HORIZON trial. While the drug successfully lowered lipoprotein(a) levels in over 8,000 patients, it did not reduce the composite risk of cardiovascular death, non-fatal heart attack, non-fatal stroke, or urgent coronary revascularization.

Separately, Novo Nordisk halted two late-stage trials of ziltivekimab. An independent data monitoring committee determined the trials were unlikely to produce results different from a previous failed study testing the inflammation hypothesis via the interleukin-6 pathway.

While these failures impact the medium-term outlook for patients whose cardiovascular risks are not addressed by current treatments, standard therapies for high cholesterol and cardiovascular risk remain unchanged.