Alnylam Pharmaceuticals Says FDA Panel Votes in Favor of Onpattro's sNDA

By Sabela Ojea

Alnylam Pharmaceuticals said that it received a positive review from the U.S. Food and Drug Administration regarding its supplemental new drug application to treat a heart disease through its Onpattro drug.

The biopharmaceutical company said 9 out of 12 members of the cardiovascular and renal drugs Advisory committee voted that the benefits of its medication outweigh its risks for the treatment of cardiomyopathy of ATTR amyloidosis.

Transthyretin amyloid cardiomyopathy is a rare but severe cause of cardiomyopathy that takes place as a result of an accumulation of the transthyretin protein.

"We look forward to continuing to work with the FDA as they complete their review of our sNDA," said Pushkal Garg, Alnylam's chief medical officer.

Earlier on Wednesday, Alnylam Pharmaceuticals shares were halted from trading while the regulatory advisory committee met to review its sNDA.

Write to Sabela Ojea at sabela.ojea@wsj.com

(END) Dow Jones Newswires

September 13, 2023 17:33 ET (21:33 GMT)

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