Novo Nordisk seeks US, EU approval for sickle cell drug etavopivat
NVO•Novo Nordisk submitted etavopivat for FDA and EMA approval to treat sickle cell disease in patients aged 12 and older, with decisions expected in 2027. Phase 3 results showed 27% fewer vaso-occlusive crises than placebo and about four months longer until the first crisis.
1. Approval applications submitted
Novo Nordisk submitted once-daily etavopivat for FDA and EMA approval to treat sickle cell disease in patients aged 12 and older. Regulatory decisions are expected in 2027. Phase 3 results showed a 27% reduction in vaso-occlusive crises versus placebo, with approximately four months longer until the first crisis.
