EU approves FREHEMGO as Novo expects sickle cell treatment filing in 2026
Key Facts
Novo Nordisk’s hemophilia treatment FREHEMGO has received European Union approval, while its regulatory application in the United States remains under review, according to the company’s third-quarter 2026 investor presentation. The company is also advancing etavopivat for sickle cell disease, following the announcement of Phase 3 results from the HIBISCUS trial. Novo said the trial recorded a 27% reduction in the annualized rate of vaso-occlusive crises, with a hemoglobin response of 48.7%. During the trial, 70% of participants were taking hydroxyurea. The company said it expected to submit the drug’s first regulatory application in the fourth quarter of 2026, while its available materials did not confirm that the application had actually been filed.
The active ingredient in FREHEMGO is denecimig, a bispecific antibody that mimics factor VIIIa and is administered subcutaneously. The treatment was designed to provide prophylaxis that can be administered weekly, every two weeks or once a month. Novo said the FRONTIER program supported the European approval recommendation. In the pivotal FRONTIER 2 trial, the annualized bleeding rate fell significantly compared with previous prophylaxis with clotting factors and on-demand treatment. The European approval marks a regulatory step for the treatment, while the U.S. review remains separate and the company materials cited did not report a decision on it.
In the HIBISCUS trial, etavopivat delayed the time to first vaso-occlusive crisis, with a median of 38.4 weeks versus 20.9 weeks with placebo, Novo said. The randomized, double-blind study ran for 52 weeks and compared a 400 mg dose of the drug with placebo. The trial included participants aged 12 years and older, and the company said 70% of participants were taking hydroxyurea. In addition to delaying the first crisis, the company reported a 27% reduction in the annualized crisis rate and a hemoglobin response of 48.7%. The results come from the same trial, which Novo presented as an efficacy and safety study.
Etavopivat is an oral, once-daily treatment that works by activating the pyruvate kinase-R enzyme, according to Novo’s investor presentation. The company says this mechanism may improve red blood cell health by reducing oxidative damage and hemolysis. In an announcement dated April 20, 2026, it said it planned to submit the drug’s first regulatory approval application in the second half of the year. The third-quarter presentation later pointed to a first filing expected in the fourth quarter of 2026, setting out the anticipated timeline in the investor materials. The announced timeline alone does not establish that a regulatory application was subsequently filed.
Novo expects to present detailed HIBISCUS trial data at the American Society of Hematology meeting in December 2026. It also said data from HIBISCUS 2, a Phase 3b trial, are expected in late 2028. For FREHEMGO, the company plans to begin its European launch near the end of 2026, with a broader rollout across the European Union during 2027. It said a U.S. launch is expected in the first half of 2027, subject to a regulatory decision. The next steps therefore include a near-term European launch, further data on the investigational drug and a pending U.S. decision on FREHEMGO.
The company says about 8 million people worldwide live with sickle cell disease, most of them in low- and middle-income countries. In the stock market, Novo Nordisk shares closed at $40.65 on November 12, 2026, according to EL7 data. Current developments combine European approval for a hemophilia treatment with clinical trial results for a drug in development for sickle cell disease. Regulatory steps and the FREHEMGO launch, along with the announced HIBISCUS data timelines, remain the company’s next milestones across the two programs.