FDA Approves Sanofi Unit's Nexviazyme for Pompe Disease
August 06 2021 - 11:43AM
Dow Jones News
By Colin Kellaher
The U.S. Food and Drug Administration on Friday said it approved
Sanofi SA's Nexviazyme for intravenous infusion to treat patients
ages 1 year and older with late-onset Pompe disease.
The agency said Nexviazyme, an enzyme replacement therapy, helps
reduce the accumulation of a complex sugar called glycogen in
skeletal and heart muscles, which cause muscle weakness and
premature death from respiratory or heart failure in patients with
the rare genetic disease.
The FDA granted approval of Nexviazyme to Genzyme, which Sanofi
acquired for $20 billion in 2011. The agency had previously granted
fast-track, breakthrough-therapy and orphan-drug designations, as
well as priority review to Nexviazyme.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 06, 2021 11:30 ET (15:30 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Sanofi (EU:SAN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sanofi (EU:SAN)
Historical Stock Chart
From Apr 2023 to Apr 2024
