Alnylam Pharmaceuticals Says FDA Panel Votes in Favor of Onpattro's sNDA
13 Setembro 2023 - 6:48PM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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