Novo Nordisk A S — Xultophy EMA EPAR public assessment report (EMEA/H/C/002647, 2014)

Novo Nordisk A S · 2014 · EMA EPAR public assessment report · company profile →

Report summary

This report summarizes the European Medicines Agency's assessment of Novo Nordisk's Xultophy (insulin degludec/liraglutide) for type 2 diabetes. Submitted in 2013, the application sought marketing authorization for this fixed-combination product. Non-clinical studies confirmed expected pharmacological effects, while clinical trials (3697, 3912, 3951, 3948) consistently demonstrated Xultophy's superior efficacy in reducing HbA1c compared to its individual components or other comparators, with a favorable impact on body weight. While common gastrointestinal adverse events and a risk of hypoglycemia were noted, Xultophy generally showed a better safety profile regarding weight and hypoglycemia compared to insulin, and fewer GI issues than liraglutide monotherapy. The CHMP recommended marketing authorization, concluding a positive benefit-risk balance.

Key findings — cited to the page

Product licensing status at submission	not licensed	Xultophy · p.4
Marketing Authorisation application submission date	31 May 2013	Xultophy · EU · p.4
Scientific Advice from CHMP	September 2010	· p.4
Responders, HbA1c <7%	79.2 %	Trial 3951 · p.46
EMA Decision P/310/2011 on paediatric waiver	P/310/2011	· p.4
Body weight Change	0.5 kg	Trial 3951 · p.46
Trial 3951 mean age	59.8 years	Trial 3951 · p.34
Body weight at baseline	87.2 kg	Trial 3951 · p.43
Procedure start date	26 June 2013	· p.5
CHMP positive opinion date	24 July 2014	Xultophy · p.5
Body weight	87.7 kg	Trial 3951 · p.46
Liraglutide (Victoza) EU-approval date	30/06/2009	Victoza · EU · p.10

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 →