Days After BridgeBio Approval, FDA Agrees to Review Alnylam’s Amvuttra in ATTR-CM

 The FDA has set a PDUFA date of March 23, 2025, for the supplemental New Drug Application based on Alnylam’s use of a Priority Review Voucher. The regulator does not plan to convene an advisory committee meeting, according to Alnyalm’s press release.

Alnylam is backing the sNDA with results from the Phase III HELIOS-B trial, in which Amvuttra lowered the risk of death and recurrent cardiovascular events in ATTR-CM. The company presented further data from HELIOS-B at the American Heart Association’s 2024 Scientific Sessions this month showing a 28% reduction in the composite of all-cause mortality and recurrent CV events.

“We are pleased that the FDA has accepted our sNDA for vutrisiran for the treatment of ATTR with cardiomyopathy – a steadily progressing, debilitating and ultimately fatal disease,” Pushkal Garg, Alnyalm’s chief medical officer, said in a statement. “We look forward to working with the FDA to support their review of the application and bring vutrisiran to patients with ATTR-CM in the U.S. early next year.”

Amvuttra is currently approved to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.

https://www.biospace.com/drug-development/days-after-bridgebio-approval-fda-agrees-to-review-alnylams-amvuttra-in-attr-cm