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Europe launch plans announced for new treatments for diabetes

With so many ongoing advances in the management of diabetes, this section keeps you up to date with product-related developments and other relevant news

Novo Nordisk announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec combined with insulin aspart) for the treatment of diabetes in adults across all EU member states.

Tresiba® is a once-daily new-generation basal insulin analogue with an ultra-long duration of action. In studies where Tresiba® was compared with insulin glargine, the new formulation demonstrated a significantly lower risk of hypoglycaemia, while successfully achieving equivalent reductions in HbA1c. Further, with a duration of action beyond 42 hours, Tresiba® is the first basal insulin to offer individuals the possibility of adjusting the time of injection when needed.

Ryzodeg® contains the once-daily new-generation basal insulin degludec in a soluble formulation with insulin aspart. It can be administered once- or twice-daily with main meals. In a study where Ryzodeg® was compared with NovoMix® (biphasic insulin aspart), the new formulation also demonstrated a significantly lower risk of hypoglycaemia while achieving reductions in HbA1c.

Novo Nordisk launched Tresiba® in the UK and Denmark in early 2013 and expects to launch it in other European markets throughout the rest of 2013 and 2014. Ryzodeg® is currently expected to be launched approximately 1 year after Tresiba®.

NICE gives approval for Lucentis® therapy
NICE has recommended that Lucentis® (ranibizumab) can be used as a treatment for visual impairment caused by diabetic macular oedema if the eye has a central retinal thickness of 400 µm or more at the start of the treatment, after Novartis submitted a revised patient access scheme and new drug data. 

Barbara Young, Chief Executive of Diabetes UK, said: “We are delighted that NICE have reconsidered their previous decision, and that this draft guidance recommends that Lucentis® is made available on the NHS, as this would mean more people with diabetes would have a better opportunity to preserve and possibly improve their vision.”

Lyxumia® (lixisenatide) launched as the first once-daily prandial GLP-1 receptor agonist
Sanofi has been granted marketing authorisation in Europe for Lyxumia® (lixisenatide). Lyxumia® is being launched as the first once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of individuals with T2D. GLP-1 is a naturally occurring peptide hormone that is released within minutes after eating a meal; it is known to suppress glucagon secretion from pancreatic alpha-cells and stimulate glucose-dependent insulin secretion by pancreatic beta-cells.

The European Commission’s decision to grant marketing authorisation for Lyxumia® was based on results from the GetGoal clinical programme, which included 11 clinical trials and involved more than 5000 individuals with T2D; 706 individuals were treated with Lyxumia® on top of basal insulin and in combination with oral antidiabetes medications in three trials. 

The clinical programme showed that Lyxumia® demonstrated significant reductions in HbA1c, a pronounced post-prandial glucose-lowering effect and a beneficial effect on body weight in adults with T2D. GetGoal results also showed that Lyxumia® had a favourable safety and tolerability profile in most individuals, with only mild and transient nausea and vomiting (the most common adverse events observed in GLP-1 receptor agonists) and a limited risk of hypoglycaemia.

Dr Bo Ahrén, Professor of Clinical Metabolic Research at Lund University, Sweden, commented: “Lyxumia® in combination with oral and/or basal insulin therapies can play a key role in meeting the important need to maintain HbA1c targets for people with T2D.”

TredaptiveTM therapy discontinued for dyslipidaemia
MSD has announced that the company will suspend the availability of Tredaptive™ worldwide, as its benefits are considered to no longer outweigh its risks. Tredaptive™ is a modified-release nicotinic acid and laropiprant tablet used to treat adults with dyslipidaemia; however, preliminary data from the HPS2-THRIVE (Heart Protection 2–Treatment of HDL to Reduce the Incidence of Vascular Events) study, funded by MSD, found that participants taking Tredaptive™ to regulate dyslipidaemia showed a statistically significant increase in the incidence of some types of non-fatal serious adverse events.

The recommendation is that physicians stop prescribing Tredaptive™ and consider other therapies to achieve dyslipidaemia management goals; individuals taking Tredaptive™ should not discontinue treatment without consultation with a healthcare professional. 

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