Alnylam CEO, ‘disappointed’ with FDA’s Onpattro rejection, pivots to the future

The recent and (mostly) surprise FDA rejection of Alnylam Pharmaceuticals’ RNAi drug Onpattro for patients with a rare genetic heart condition was a knock to the company’s market plans, and CEO Yvonne Greenstreet said she was “extremely disappointed with the outcome.”

The regulator denied approval despite a positive vote from an independent medical advisory committee earlier this year, saying in a complete response letter that Alnylam did not demonstrate clinically meaningful results in patients with cardiomyopathy of ATTR amyloidosis.