Sanofi celebrates EU approvals
pharmafile | February 5, 2013 | News story | Sales and Marketing | Lyxumia, Sanofi, Zaltrap, diabetes
Sanofi is celebrating after diabetes treatment Lyxumia (lixisenatide) and metastatic colorectal cancer (mCRC) drug Zaltrap received authorisation in Europe.
The pair were recommended by the CHMP in November, and the EC approval of Lyxumia (lixisenatide) gives extra bulk to a diabetes portfolio that already contains the world’s biggest seller, Lantus (insulin glargine).
Lyxumia, a once-daily GLP-1 receptor, will be up against Novo Nordisk’s Victoza – the leading brand in this relatively new class of injectable drugs.
Lyxumia is indicated to treat adults with type II diabetes to control blood sugar in combination with oral glucose-lowering products which may include insulin, and will be used when these, together with diet and exercise, do not provide adequate glycaemic control.
In the GetGoal Phase III programme – comprising 5,000 patients in 11 trials – it demonstrated reductions in both glycated haemoglobin (HbA1c) and post-prandial glucose.
It also helped weight loss, was safe and tolerated in most patients, and nausea and vomiting were the most common adverse events.
“We now have a simple new tool to help patients with type II diabetes further reduce HbA1c with the benefit of weight loss and limited risk of hypoglycaemia,” said Pierre Chancel, Sanofi’s senior vice-president, global diabetes.
The drug has been submitted for approval in other countries, including the US.
Meanwhile Zaltrap (aflibercept), co-marketed with Regeneron, will be used in previously treated mCRC with irinotecan/5-fluorouracil/folinic acid (Folfiri) chemotherapy in adults whose disease is resistant to, or has progressed after, an oxaliplatin-containing regimen.
It has already been approved by the FDA after a priority review, the anti-VEGF cancer drug performing well in the Phase III VELOUR trial, improving median survival from 12.06 months to 13.5 months when added to Folfiri.
Progression-free survival also improved, from 4.67 months to 6.9 months, while the overall response rate in the Zaltrap plus Folfiri arm was 19.8% versus 11.1% for Folfiri alone.
Colorectal is the most common cancer in both men and women in Europe and the second leading cause of cancer mortality: in 2008, there were 436,000 new cases diagnosed and 212,000 deaths.
“The European approval of Zaltrap provides a new option to address the unmet medical need in this patient population,” said George Yancopoulos, chief scientific officer of Regeneron.
The drug faces competition in mCRC from the likes of Roche’s Avastin, Bayer’s Stivarga, Bristol-Myers Squibb/Merck Serono’s Erbitux and Amgen’s Vectibix.
Zaltrap is late to the market and seems less likely to receive other licences – failing in studies for prostate, lung and pancreatic cancer, and colorectal cancer – but is still predicted to make peak annual sales of up to $400 million.
Adam Hill
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