Morningstar

Novo Gets EU Drug Regulator Backing for Hemophilia Drug

Provided by Dow Jones Sep 17, 2026, 2:47:00 PM

By Adria Calatayud

Novo Nordisk said a key European Medicines Agency committee recommended the approval of its Frehemgo drug for hemophilia A.

The Danish drugmaker said Thursday that it expects to launch the medicine in the first European countries in the fourth quarter, and more broadly across the European Union starting early next year.

The committee for medicinal products for human use of the European Medicines Agency issued a positive opinion on the drug--designed to prevent or reduce the frequency of bleeding episodes in hemophilia A patients--for the treatment of adults and children, the company said. It is now up to the European Commission, the EU's executive arm, to decide on the product's approval.

Novo said it submitted the drug for U.S. Food and Drug Administration review in September last year.

Write to Adria Calatayud at adria.calatayud@wsj.com

(END) Dow Jones Newswires

September 17, 2026 10:47 ET (14:47 GMT)

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