Alnylam Ending Onpattro ATTR-CM Pursuit After FDA Rejection
09 Outubro 2023 - 9:23AM
Dow Jones News
By Colin Kellaher
The U.S. Food and Drug Administration has rejected Alnylam
Pharmaceuticals' request for expanded approval of Onpattro for
transthyretin-mediated amyloidosis with cardiomyopathy, or ATTR-CM,
citing insufficient evidence of clinical meaningfulness.
Alnylam on Monday said it no longer plans to pursue the expanded
indication after the FDA issued a so-called complete response
letter, indicating the agency won't approve the application in its
current form.
Alnylam said the FDA found that the Cambridge, Mass., company
hadn't established the clinical meaningfulness of Onpattro's
treatment effects for the cardiomyopathy of ATTR amyloidosis.
An FDA advisory committee last month had voted that the benefits
of Onpattro outweigh its risks for the treatment of the
cardiomyopathy of ATTR amyloidosis, but panel members also
suggested that the drug would only be useful for patients who
worsen while receiving Pfizer's tafamidis franchise of Vyndaqel and
Vyndamax, and some Wall Street analysts had cautioned that the
FDA's ultimate decision would be a tossup.
Alnylam said the FDA didn't identify any issues with clinical
safety, drug quality or manufacturing, adding that the decision
doesn't affect Onpattro for its approved indication in the
polyneuropathy of hereditary ATTR amyloidosis in adults.
Trading in shares of Alnylam, which closed Friday at $176.92,
was halted premarket on Monday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 09, 2023 08:08 ET (12:08 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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