Sanofi withdraws lixisenatide US application
pharmafile | September 12, 2013 | News story | Sales and Marketing | FDA, Lixisenatide, Sanofi, diabetes, elixa
In a blow to its diabetes pipeline, Sanofi has withdrawn a new drug application (NDA) for lixisenatide in the US and now plans to resubmit it in 2015.
Already approved as Lyxumia in Europe, the drug has hit a roadblock with the FDA over the way the regulator wants to review interim data from the ongoing ELIXA cardiovascular (CV) outcomes study.
“Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study,” the company said in a statement.
The decision has nothing to do with safety or with ‘deficiencies’ in the NDA, Sanofi insists – it is purely an issue around the use of interim data.
As full results from ELIXA will be available in around 15 months, the manufacturer believes the ‘most appropriate’ course of action is to wait for the trial to be completed and then approach the FDA once more.
“Sanofi looks forward to working with the FDA in the future to resubmit the lixisenatide NDA,” the company added.
But such a delay of a large potential revenue stream will be unwelcome for Sanofi – and the news is particularly disappointing for Zealand Pharma, from whom Sanofi licenced lixisenatide.
Lyxumia, a once-daily GLP-1 receptor, is to be a key weapon in the fight against Novo Nordisk’s Victoza – the leading brand in this relatively new class of injectable drugs.
Sanofi’s diabetes portfolio already contains the world’s biggest seller, Lantus (insulin glargine), and the combination of lixisenatide and Lantus – the investigational LixiLan fixed-ratio product – remains on track to go into Phase III in the first half of next year.
Lyxumia is indicated in the European Union to treat adults with type 2 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.
ELIXA, which began more than three years ago, is looking at 6,000 patients worldwide who are at a high CV risk, having recently experienced an acute coronary event.
Adam Hill
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