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)

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