05.02.2013 - The European Commission has granted EU market authorisation to Sanofi’s GLP-1 receptor agonist licisenatide as a diabetes therapy.
The first in class once-daily prandial GLP-1 (glucagon-like peptide-1) receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as a second line therapy. The decision of the Commission to approve the drug for patients that do not respond to a combination of oral glucose-lowering medicinal products plus basal insulin as well as diet and exercise is based on results from the GetGoal clinical programme
In 11 studies on 5,000 patients, the Paris-based drug maker demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia (licisenatide) had a favourable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycaemia, according to Sanofi.
The therapy, which was licensed from Danish Zealand Pharma A/S in a €170m deal, is indicated when first-line therapy proves no longer effective over time. It strengthens Sanofi’s leading position in the €12bn diabetes market. 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
30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.
16.04.2015 The Swiss biotech industry can look back on 2014 as a good year, but political uncertainties do remain. This was one of the topics discussed during the Swiss Biotech Day in Basel, which attracted more than 400 participants.
14.04.2015 Belgian Thrombogenics NV has launched a new oncology company with Gent-based life sciences institute VIB. The new venture will develop an antibody for the treatment of a fast-growing brain tumour that affects children and adolescents.