Novartis Says EMA Recommends Multiple Sclerosis Drug Mayzent
November 15 2019 - 07:15AM
Dow Jones News
By Carlo Martuscelli
Novartis AG (NOVN.EB) said Friday that the European Medicines
Agency recommended Mayzent as a treatment for adult patients with
secondary progressive multiple sclerosis.
The EMA's Committee for Medicinal Products for Human Use gave a
positive opinion on the drug as a treatment for adult patients who
show evidence of relapse or inflammatory activity, the Swiss drug
maker said.
In most cases a recommendation by the CHMP leads to marketing
approval from the European Commission.
Novartis said that the decision is based on positive results
from the Phase 3 Expand trial which showed that Mayzent was able to
slow the progress of SPMS in treated patients.
The U.S. approved the drug for relapsing forms of multiple
sclerosis in March.
Novartis said that regulatory filings to secure approval for
Mayzent were underway in Switzerland, Japan, Canada, and China.
Write to Carlo Martuscelli at carlo.martuscelli@wsj.com;
@carlomartu
(END) Dow Jones Newswires
November 15, 2019 07:00 ET (12:00 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Novartis (NYSE:NVS)
Historical Stock Chart
From Feb 2024 to Mar 2024
Novartis (NYSE:NVS)
Historical Stock Chart
From Mar 2023 to Mar 2024