European nod for Sanofi drugs
pharmafile | November 19, 2012 | News story | Research and Development, Sales and Marketing | CHMP, Sanofi
Two of Sanofi’s key drugs have cleared the penultimate hurdle to approval in Europe with a recommendation from the CHMP.
Diabetes treatment Lyxumia (lixisenatide) and metastatic colorectal cancer (mCRC) drug Zaltrap (aflibercept) – which is co-marketed with Regeneron – have both been given the nod by the European Medicines Agency committee, paving the way for market authorisation.
The European Commission generally concurs with CHMP opinions within three months, which means Sanofi is poised for a welcome boost in the early part of 2013.
The CHMP is recommending once-daily GLP-1 receptor agonist Lyxumia to treat adults with type II diabetes to control blood sugar in combination with oral glucose-lowering products which may include insulin.
It would be used when these, together with diet and exercise, do not provide adequate glycaemic control after demonstrating in the GetGoal Phase III trial reductions in both glycated haemoglobin (HbA1c) and post-prandial glucose.
Sanofi already has the world’s biggest-selling diabetes treatment – the long-acting insulin analogue Lantus (insulin glargine) which earned around €4 billion ($5.2 billion) in 2011.
But the manufacturer is in a fierce battle with Novo Nordisk, whose Victoza is the leading GLP-1 analogue – part of this relatively new class of injectable drugs in which Lyxumia hopes to dominate.
It is a lucrative area: some estimates suggest that there will be 380 million diabetics worldwide by 2025. Sanofi says it will submit Lyxumia to the FDA next month.
The company’s diabetes franchise overall earned $7.36 billion last year, just behind Novo, which made $8.91 billion.
The positive opinion in Europe for Sanofi’s Zaltrap in previously treated mCRC would see it used with irinotecan/5-fluorouracil/folinic acid (Folfiri) chemotherapy in adults whose disease is resistant to, or has progressed after, an oxaliplatin-containing regimen.
Approved by the FDA in August following a priority review, the anti-VEGF cancer drug performed 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.
While the drug has failed in studies for prostate, lung and pancreatic cancer, colorectal cancer is the third most commonly-diagnosed cancer in men and the second in women, with more than 1.2 million new cases and 600,000 deaths globally in 2008 alone.
But Zaltrap will have significant competition in mCRC from, among others, Roche’s Avastin, Bayer’s Stivarga, Bristol-Myers Squibb/Merck Serono’s Erbitux and Amgen’s Vectibix.
As Zaltrap is late to the market and seems less likely to receive other licences, analysts have predicted peak annual sales of around $300 million to $400 million – some way below Avastin and Erbitux.
Adam Hill
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