FDA Approves Zevra's Miplyffa for Niemann-Pick Disease Type C
Provided by
Dow Jones
By Colin Kellaher
Zevra Therapeutics has won Food and Drug Administration approval of Miplyffa for Niemann-Pick disease type C, making it the first drug cleared in the U.S. for the rare neurodegenerative disorder.
The FDA on Friday said the approval covers Miplyffa in combination with the enzyme inhibitor miglustat to treat neurological symptoms associated with the disease in people ages two and older.
An FDA advisory committee last month recommended approval of Miplyffa for Niemann-Pick disease type C.
Trading in shares of the Celebration, Fla., company was halted Friday morning.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 20, 2024 11:14 ET (15:14 GMT)
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