Moderna Gets FDA Breakthrough Designation for RSV Vaccine Candidate
30 Janeiro 2023 - 10:08AM
Dow Jones News
By Colin Kellaher
Moderna Inc. on Monday said the U.S. Food and Drug
Administration granted breakthrough-therapy designation to its
mRNA-1345 investigational vaccine candidate for respiratory
syncytial virus, or RSV.
The Cambridge, Mass., vaccine maker said the designation covers
mRNA-1345 for the prevention of RSV-associated lower respiratory
tract disease in adults ages 60 and older.
The FDA's breakthrough-therapy designation aims to expedite the
development and review of a drug for serious conditions when
preliminary clinical evidence shows the drug may show substantial
improvement over available therapies.
Moderna said mRNA-1345, which uses the same messenger RNA
technology as its blockbuster Covid-19 vaccines, won the
designation based on positive topline data from a Phase 3 study
that showed vaccine efficacy of 83.7% against RSV lower respiratory
tract disease, defined by two or more symptoms in older adults.
The company said it plans to file for FDA approval of the
vaccine in the first half of the year.
RSV, a common respiratory virus that people get many times over
the course of their lives, can cause serious illness in the very
old and young. There are currently no FDA-approved prophylactic,
therapeutic or vaccine options for RSV for older adults.
Moderna rival Pfizer Inc. in December said the FDA had granted
priority review with a target action date in May for its RSV
vaccine candidate for the prevention of lower respiratory tract
disease in older adults.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 30, 2023 07:53 ET (12:53 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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