A new injectable drug has been approved for use in the EU to help control type 2 diabetes, alongside basal insulin or oral medication.

Lyxumia (lixisenatide) from Sanofi is the first once-daily prandial GLP-1 receptor agonist, a drug that stimulates the pancreas to produce more insulin during meals.

Licensed by Sanofi from Danish biotechnology company Zealand Pharma, Lyxumia can improve blood glucose control by reducing the ‘peaks’ induced by meals.

It is indicated for adjunctive use together with basal insulin or an oral glucose-reducing drug when these alone do not deliver effective control.

The approval was based on the GetGoal clinical trial programme, which involved more than 5,000 patients with type 2 diabetes and showed that Lyxumia achieved a marked post-prandial reduction in blood glucose and a significant long-term HbA1c reduction.

It also helped to reduce body weight, and its side-effects (nausea and vomiting) were short-lived. Risk of hypoglycaemia was limited.

“Patients with Type 2 diabetes are not all alike,” said Dr Filip K. Knop of Gentofte Hospital, University of Copenhagen. “One issue is that patients treated with basal insulin often move away from their target HbA1c despite well-controlled fasting plasma glucose.

“Adding a short-acting GLP-1 receptor agonist with a pronounced effect on post-prandial glucose, like once-daily Lyxumia, may be a good way of getting these patients back at target without increasing the risk of hypoglycaemia.”

Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA): it enhances the action of GLP-1, a naturally occurring peptide hormone that is released while eating a meal and stimulates insulin secretion by pancreatic cells.

Sanofi has in-licensed the drug from Zealand Pharma, who will receive low double-digit percentage royalties on global sales.

Sales increased more than 10% at Sanofi in the third quarter to €8.7 billion, despite the loss of €471 million due to generic competition compared to the same period a year ago.

Total sales grew 10.1% along with an 11% increase in growth platforms after strong performances in its diabetes, vaccines and consumer health divisions.

Christopher A. Viehbacher, Sanofi CEO, says the return to growth in sales and earnings is an “important milestone as the company progressively puts the patent cliff behind it”.

Growth platforms and Genzyme accounted for 68.5% of total sales after the recently acquired business recorded sales up 6.9% to €768 million.

Pharmaceutical net sales were up a tenth to €6.9 billion and helped year-to-date net sales rise 5.5% to €20 billion, despite generic competition to Lovenox, Ambien CR and Taxotere in the US and Plavix (pictured) and Taxotere in the EU plus the impact of US healthcare reform and EU austerity measures.

Its diabetes division was driven by a strong US and Emerging Markets performance which resulted in a 12.4% increase in sales after Lantus recorded growth of 14.6% and 23.4%, in respective markets. Growth in Sanofi’s vaccine division also increased 16.7% after a solid demand for seasonal flu medication in the US.

The Sanofi Group now expects 2011 business net income to be between 2%-5% lower than last year’s total. “We continue to make strong progress in R&D with the submission of five new products and also in the tight control of our costs,” said Mr Viehbacher.

It was reported this week that Sanofi is set to overtake Pfizer as the world’s biggest pharmaceutical company by 2016.

Submissions have been recently filed for Lyxumia (lixisenatide) in the EU, Aubagio (teriflunomide) and Zaltrap (aflibercept) in the US; Visamerin/Mulsevo (semuloparin) in the US and EU; plus Kynamro (mipomersen) in the EU.

The company released its Q3 performance on the day it announced it was cutting jobs in its US R&D and sales divisions.

Lixisenatide once-daily has been proven to be equally as effective as the current licensed twice-daily therapy in treating type 2 diabetes.

A recent Phase III trial also showed that lixisenatide caused fewer hypoglycaemic events than another GLP-1 receptor agonist, exenatide (Byetta) twice-daily (8 vs. 48 events).

The primary endpoint of the GetGoal-X Phase III study of lixisenatide was non-inferiority in HbA1c reduction from baseline, when used as add-on therapy for people with type 2 diabetes whose condition was inadequately controlled by metformin.

Dr Andrew Hockey (pictured), Director of Medical Operations, sanofi-aventis UK, commented: “The lixisenatide clinical development programme exemplifies our commitment to people with diabetes and our ambition to help them manage their condition more effectively.”

A total of 639 people were involved in the GetGoal-X clinical trial, which had a 24-week main treatment period.