Novo Nordisk files for US and EU approval of sickle cell pill, rulings due 2027
Novo Nordisk has submitted etavopivat, a once-daily oral therapy for sickle cell disease, to both the FDA and the European Medicines Agency, with decisions expected in 2027. The filing rests on Phase 3 HIBISCUS data showing a 27% drop in vaso-occlusive crises versus placebo and a first-crisis delay of about four months.
- Original source: foreignpolicyjournal.com.
- The source published it on Nov 14, 2026 at 11:24 AM.
- No second outlet has reported it yet. Treat it as a single-source claim.
Novo Nordisk (NYSE: NVO) has filed for marketing approval of etavopivat with the US Food and Drug Administration and the European Medicines Agency, seeking a green light for the once-daily pill in sickle cell disease patients aged 12 and older. Both regulators are expected to rule in 2027. The company hasn't yet published complete efficacy and safety data from the Phase 3 HIBISCUS programme.
The topline HIBISCUS results, disclosed in April 2026, showed etavopivat cut the rate of vaso-occlusive crises by 27% compared with placebo and delayed the first such crisis by roughly four months. Patients were allowed to stay on their existing standard-of-care regimens during the trial, so the drug was tested as an add-on rather than a replacement.
Vaso-occlusive crises occur when misshapen red blood cells block circulation, causing painful episodes that can drive organ complications and erode quality of life. Etavopivat goes after the problem by selectively activating the red blood cell isozyme of pyruvate kinase, an enzyme at the centre of cellular energy metabolism, a mechanism meant to improve how abnormal red blood cells function.
Martin Holst Lange, Novo Nordisk's Executive Vice President and Chief Scientific Officer, said the submission lands against a backdrop of scarce options, stating that "treatment options remain limited" for people living with the condition.
Etavopivat carries several regulatory perks going into review: Fast Track, Rare Pediatric Disease and Orphan Drug designations from the FDA, plus Orphan Drug status from the European Commission. Those tags recognise the unmet need and the drug's development profile, but they don't guarantee approval.
Novo Nordisk plans to present the full HIBISCUS results at a scientific conference and submit them to a peer-reviewed journal. The dual filing also marks a deliberate push beyond the Danish company's core diabetes and obesity franchises into rare disease, where competition is thinner but patient numbers are smaller.
TopicsNovo Nordisk · NYSE: NVO · etavopivat · FDA · European Medicines Agency · Martin Holst Lange · HIBISCUS · European Commission
Source: foreignpolicyjournal.com
Written by Paparazzi with AI. Not financial advice.
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