Morningstar

Novo Nordisk Receives EU Approval for Hemophilia Drug

Provided by Dow Jones Nov 13, 2026, 5:31:00 PM

By Mauro Orru

Novo Nordisk said it had received approval from the European Union to sell its Frehemgo drug as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

The Danish drugmaker said the European Commission, the EU's executive arm, had granted marketing authorization for Frehemgo that will allow patients to receive doses once a month, once every two weeks or once a week using a single-use prefilled pen.

The Committee for Medicinal Products for Human Use of the European Medicines Agency had issued a positive opinion for Frehemgo in September. Frehemgo has also been approved in Saudi Arabia and is under review by the U.S. Food and Drug Administration and other regulators.

Write to Mauro Orru at mauro.orru@wsj.com

(END) Dow Jones Newswires

November 13, 2026 12:31 ET (17:31 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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