Arrowhead Pharmaceuticals announced positive Phase 3 topline results from its SHASTA-3 and SHASTA-4 studies of plozasiran, which successfully met the primary endpoint of reducing triglycerides in patients with severe hypertriglyceridemia. Following this, the CHMP issued a positive opinion recommending marketing authorization for Ubeslo and Evlarco in Europe. On July 25, NewAmsterdam Pharma and Menarini Group received this formal recommendation to advance the commercialization of these treatments.
The CHMP issued a positive opinion for Ubeslo and Evlarco, clearing a major regulatory path for European marketing authorization of the cardiovascular treatments.
Read the full storyThe CHMP recommends marketing authorization for Ubeslo and Evlarco following successful Phase 3 clinical trials for hypercholesterolemia.
Phase 3 SHASTA-3 and SHASTA-4 studies met primary endpoints for triglyceride reduction in patients with severe hypertriglyceridemia.