Date: 2017-06-22
Type of information: Granting of a Market Authorisation in the US
Product name: Victoza®
Compound: liraglutide
Therapeutic area: Metabolic diseases
Action mechanism:
- Glucagon-like Peptide 1 (GLP-1) analogue. This human Glucagon-Like Peptide-1 (GLP-1) analogue works by stimulating the release of insulin from the pancreatic beta cells only when blood sugar levels are high.
Company: Novo Nordisk (Denmark)
Disease:
- type 2 diabetes - reduction of risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease
Latest news:
- • On August 25, 2017, the FDA has approved a new indication for Victoza® (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease. The FDA's decision is based on the results from the LEADER trial, which demonstrated that Victoza® statistically significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo, when added to standard of care, with an absolute risk reduction of 1.9%. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza® treatment vs placebo, with an absolute risk reduction of 1.3%, and non-significant reductions in non-fatal heart attack and non-fatal stroke.
- • On June 22, 2017, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP), has issued a positive opinion on update of the EU label for Victoza®. The update is based on the results from the LEADER trial which investigated the long-term effects of Victoza® (liraglutide up to 1.8 mg) in people with type 2 diabetes, at high risk of major cardiovascular (CV) events.
- In the LEADER trial, Victoza® (liraglutide up to 1.8 mg) statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13% versus placebo, when added to standard of care. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza® treatment versus placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke.
- The CHMP has recommended an update of the indication for Victoza® to reflect both glycaemic control and cardiovascular events as integral parts of type 2 diabetes treatment. Novo Nordisk expects to receive the European Commission decision for the Victoza® label update in the third quarter of 2017.
- • On June 20, 2017, Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has completed its meeting regarding the supplemental New Drug Application (sNDA) for inclusion of the data from the cardiovascular outcomes trial LEADER in the label for Victoza® (liraglutide). The Advisory Committee voted 19-0 in favour of Victoza® on the question: "Do the results of LEADER establish that use of Victoza® in patients with type 2 diabetes is not associated with excess cardiovascular risk?". The Advisory Committee voted 17-2 in favour of Victoza® on the question: "Does the LEADER trial provide the substantial evidence needed to establish that Victoza® (liraglutide 1.8 mg) reduces cardiovascular risk in patients with type 2 diabetes?"
- The supplemental New Drug Application for Victoza® was submitted to the FDA in October 2016 and regulatory feedback in the US is expected in Q3 2017. In Europe, a Type II Variation application was submitted to the European Medicines Agency (EMA) in October 2016.
- • On November 21, 2014, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the use of Victoza® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. The CHMP recommendation for Victoza® was based on efficacy and safety data from the LIRA-RENAL phase 3b clinical trial. The LIRA-RENAL study is a 26-week, double-blind, randomised, controlled study that investigated the efficacy and safety of Victoza® compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination thereof in adults with type 2 diabetes and moderate renal impairment. The addition of once-daily Victoza® versus placebo in adults with type 2 diabetes and moderate renal impairment showed statistically significantly greater reduction in mean HbA1c (-1.05% vs. -0.38%) and body weight (-2.41 kg vs -1.09 kg). Adults treated with Victoza® experienced no change in renal function (estimated glomerular filtration rate [eGFR] (Modification of Diet in Renal Disease [MDRD]) change from baseline: liraglutide -1%; placebo +1%).
- There was a comparable risk of hypoglycaemic episodes between the two treatment groups. The safety profile of Victoza® was generally similar to that observed in other studies of the treatment
• On 20 March 2014, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for Victoza®. The CHMP adopted a new indication to include the combination of Victoza® with basal insulin. The full indication for Victoza now reads as follows: “Victoza is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with: oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.”
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-08-25
UE authorization: 2009-06-30
Favourable opinion UE: 2017-06-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
- • On November 10, 2015, Novo Nordisk announced that new findings from a health economics and outcomes research (HEOR) analysis demonstrated that Victoza® (liraglutide) 1.2 mg is cost-effective for the treatment of type 2 diabetes in the UK market when compared to lixisenatide and is cost-saving compared to exenatide.
Findings were presented at the 18th Annual European Congress of the International Society for Pharmacoeconomics
and Outcomes Research (ISPOR) in Milan, Italy. The analysis assessed the cost-effectiveness of liraglutide (1.2 mg), exenatide (10 µg BID) and lixisenatide (20 µg), prescribed for the treatment of type 2 diabetes in the UK.
Liraglutide (1.2 mg) was found to be cost-effective versus lixisenatide, with an incremental cost-effectiveness ratio (ICER)† of £7,367 per QALY* gained. Liraglutide (1.2 mg) was associated with cost-savings of £87 versus exenatide 10 ?g BID. The analysis was based on changes seen in blood glucose level (HbA1c), blood pressure and body mass index on initiation of each treatment, taken from a network metaanalysis of 13 randomized controlled trials. These trials evaluated the efficacy and safety of GLP-1 receptor agonists for the treatment of people with type 2 diabetes uncontrolled on oral antidiabetic drugs.
Is general: Yes
