Novo Nordisk A S — Kayshild EMA EPAR public assessment report (EMEA/H/C/006426, 2026)
Novo Nordisk A S · 2026 · EMA EPAR public assessment report · company profile →
Report summary
The EMA has granted conditional marketing authorization for Novo Nordisk's Kayshild (semaglutide) for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (F2-F3). This decision, based on a positive CHMP opinion, acknowledges Kayshild's significant efficacy in resolving MASH and improving fibrosis, as demonstrated in clinical trials (e.g., 4296, 4553). Non-clinical studies supported its indirect mechanism of action on MASH. While generally consistent with semaglutide's known safety profile, including common gastrointestinal adverse events, the authorization is conditional on further data from the ongoing Phase III ESSENCE trial (NN9931-4553) by December 2029 to confirm long-term benefits and safety. Kayshild, presented as a solution for injection in a multi-dose pen, addresses an unmet medical need.
Key findings — cited to the page
| Final indication | Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3). | · p.10 |
| Application submission date | 4 March 2025 | EU · p.12 |
| Applicant | Novo Nordisk A/S | · p.10 |
| Product name | Kayshild | · p.10 |
| Active substance | Semaglutide | · p.10 |
| EMA product number | EMEA/H/C/006426 | · p.10 |
| ATC code | A10BJ06 | · p.10 |
| Pharmaceutical form and strengths | Solution for injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg | · p.10 |
| Route of administration | Subcutaneous use | · p.10 |
| Type of marketing authorisation granted at opinion | Conditional | · p.10 |
| Legal basis | Article 8.3 of Directive 2001/83/EC | · p.10 |
| Scientific advice date (non-clinical and clinical) | 15 October 2020 | · p.11 |
Source: Novo Nordisk A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →