CHMP issues positive opinion for expanded use of Tresiba & Victoza in type 2 diabetes

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The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for expanded use of Tresiba (insulin degludec) and Victoza (liraglutide) in type 2 diabetes.

Once the European Commission approves the label expansion, physicians will be able to prescribe Tresiba, the once-daily, long-acting basal insulin in combination with GLP-1 receptor agonists, such as Victoza. Similarly, Victoza, the once-daily human glucagon-like peptide-1 (GLP-1 analogue), can be prescribed in combination with a basal insulin.

Tresiba was approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes as a monotherapy and in combination with oral anti diabetic (OAD) medicinal products or with mealtime insulin1. Victoza was approved in Europe in 2009 for the treatment of type 2 diabetes in adults in combination with OADs.

“This is excellent news for patients with type 2 diabetes and their physicians. The update expands the options physicians have to individualise therapy for their patients and help them achieve glycaemic targets, especially if they have concerns about hypoglycaemia and weight gain,” said Professor Chantal Mathieu, Katholieke Universiteit Leuven, Belgium, the lead study investigator of the BEGINT: VICTOZA ADD-ON trial.

The CHMP recommendation for both Tresiba and Victoza was based on efficacy and tolerability data from four phase 3 clinical trials. All four trials were conducted in adults with type 2 diabetes.

Pivotal data came from the BEGINT: VICTOZA ADD-ON3 26-week open-label extension to a 104-week clinical trial in which 57% of patients treated with Tresiba in combination with metformin achieved a target HbA1c <7%. Patients who did not achieve the HbA1c target were randomised to receive either a single dose of NovoRapid (insulin aspart), with the largest meal or once-daily Victoza in addition to Tresiba and metformin for 26 weeks.

Tresiba (insulin degludec) is the global brand name for insulin degludec, a basal insulin discovered and developed by Novo Nordisk. Once-daily Tresiba provides a long duration of action beyond 42 hours, allowing for flexibility in day-to-day dosing time when needed with a minimum of eight hours and a maximum of 40 hours between injections, without compromising efficacy or risk of hypoglycaemia. Tresiba has been studied in a large-scale clinical trial programme, BEGINT, examining its impact on glucose control, hypoglycaemia and flexibility in day-to-day dosing time when needed. Tresiba has received regulatory approval in Argentina, Aruba, Bangladesh, Brazil, Chile, El Salvador, the EU, Iceland, India, Japan, Lebanon, Lichtenstein, Macedonia, Mexico, Norway, Russia and Switzerland.

Victoza (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycaemia. In addition, Victoza reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered food intake.

Victoza was launched in the EU in 2009 and is commercially available in more than 65 countries globally. Currently, there are more than 790,000 patients receiving Victoza worldwide7. In the US, Victoza was approved on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Source: PharmaBiz

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