Novo Nordisk Scores EU Win For Hemophilia Drug, Advances Sickle Cell Treatment Toward Approval

Novo Nordisk (NYSE:NVO) announced on Friday that European regulators approved its hemophilia A therapy, Frehemgo, while the company filed U.S. and European marketing applications for its sickle cell disease candidate, etavopivat.

The European Commission authorized Frehemgo (denecimig) as a routine preventive treatment to reduce bleeding episodes in adults and children with hemophilia A, with or without inhibitors.

The decision follows a September 2026 positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

European Approval Expands Hemophilia A Treatment Options

Patients and healthcare teams can inject Frehemgo, a next-generation FVIIIa mimetic bispecific antibody, under the skin using a single-use pre-filled pen.

The therapy offers once-weekly, every-two-weeks, or once-monthly dosing. Saudi Arabia approved the drug, and the U.S. Food and Drug Administration is reviewing it.

Results from the FRONTIER clinical trial program back the authorization. In the pivotal FRONTIER2 trial, denecimig significantly lowered annualized bleeding rates compared with prior clotting factor prophylaxis and on-demand treatments.

Data from FRONTIER3 confirmed consistent efficacy in children under 12, with many participants across the program achieving zero treated bleeds.

The FRONTIER5 study showed that switching directly from emicizumab to denecimig raised thrombin generation into normal ranges without new safety signals or thrombotic risks, while patients favored the pen.

Novo Nordisk Submits Etavopivat For Sickle Cell Disease

Novo Nordisk also submitted a New Drug Application to the FDA and a Marketing Authorization Application to the EMA for etavopivat.

The company acquired this once-daily, oral selective pyruvate kinase red blood cell isozyme activator through its 2022 purchase of Forma Therapeutics to treat sickle cell disease in patients aged 12 and older.

Data from the HIBISCUS study program support both filings.

In April 2026, topline results showed that etavopivat reduced annualized vaso-occlusive crises by 27% and delayed the first crisis by roughly four months compared with a placebo.

Both the FDA and the European Commission previously granted etavopivat Orphan Drug designation, with the FDA adding Fast Track and Rare Pediatric Disease statuses. Both regulators expect to decide on approval in 2027.

NVO Price Action: Novo Nordisk shares were up 1.69% at $41.33 at the time of publication on Friday, according to Benzinga Pro data.

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