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Date: 2018-02-08

Type of information: Granting of a Market Authorisation in the EU

Product name: Ozempic®

Compound: semaglutide

Therapeutic area: Metabolic diseases

Action mechanism:

  • glucagon-like Peptide 1 (GLP-1) analogue. Semaglutide is a human GLP-1 (Glucagon-Like Peptide-1) analogue developed for once-weekly treatment of type 2 diabetes patients. The mechanism behind blood glucose lowering and reduction of body weight follows the same principles as liraglutide (Victoza®); however, with a longer intrinsic circulation half-life. Hence, the semaglutide molecule has a pharmacokinetic profile particularly suitable for once-weekly subcutaneous administration.

Company: Novo Nordisk (Denmark)

Disease: type 2 diabetes

Latest news:

  • • On February 8, 2018, the European Commission has granted marketing authorisation for Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes. The drug is indicated as monotherapy when metformin is considered inappropriate due to intolerance or is contraindicated, and as an addition to other medicinal products for the treatment of diabetes. The marketing authorisation applies to all 28 European Union member states. The label reflects the superior and sustained reductions in HbA1c and body weight achieved with Ozempic® relative to comparator treatments, cardiovascular benefits and the statistically significant reduction in diabetic nephropathy with Ozempic® relative to standard of care.
  • Ozempic® has been approved in the EU for use in a multi-dose Ozempic® pen, the latest generation of Novo Nordisk prefilled devices. However, Novo Nordisk intends to submit a variation application to the European Medicines Agency (EMA) seeking approval of an updated Ozempic® pen offering. The new pen offering will help facilitate reimbursement for patients with type 2 diabetes using Ozempic®. The launch of Ozempic® is expected to take place in the first EU countries in the second half of 2018 following the approval of the variation application for the updated pen offering.
  • • On December 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Ozempic® intended for the treatment of type 2 diabetes. Ozempic® will be available as a 1.34 mg/ml solution for injection. The benefits with Ozempic® are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with other glucose-lowering medicinal products or on its own when metformin cannot be used. Ozempic® has also a beneficial effect on body weight. The most common side effects are hypoglycaemia when used in certain combinations and gastrointestinal side effects such as nausea and diarrhoea.
  • • On December 5, 2017, the FDA has approved Ozempic® (semaglutide injection). Ozempic® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The approval of Ozempic® is based on the results from the SUSTAIN clinical trial programme and follows a positive recommendation from an FDA Advisory Committee meeting on 18 October 2017. In people with type 2 diabetes, Ozempic® produced clinically meaningful and statistically significant reductions in HbA1c compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100. Furthermore, in the trials, treatment with Ozempic® resulted in statistically significant reductions in body weight. Ozempic® demonstrated a safe and well-tolerated profile across the SUSTAIN programme with the most common adverse event being mild to moderate nausea, which diminished over time. Ozempic® is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and will be launched in the Ozempic® Pen, the latest generation of Novo Nordisk prefilled devices.

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: 2017-12-05

UE authorization: 2018-02-08

Favourable opinion UE: 2017-12-14

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes