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Sanofi loses lead on diabetes combo IGlarLixi after FDA delay

FDA verdict on Novo Nordisk’s rival combo Xultophy due next month 

Sanofi reception 

The FDA has asked for more information on Sanofi and Zealand Pharma's IGlarLixi combination drug for diabetes, giving a rival drug from Novo Nordisk a chance to be first to the US market.

The US regulator has asked for more data on the pen injector device used with IGlarLixi, which combines the active ingredients in Sanofi's Lantus (insulin glargine) with GLP-1 agonist Lyxumia (lixisenatide), and has extended its review period by three months.

That is an expensive blow to Sanofi, which spent $245m on the purchase of a priority review voucher in order to overtake Novo Nordisk and its insulin/GLP-1 agonist combination IDeglira/Xultophy (insulin degludec/liraglutide).  The FDA is due to deliver a verdict on Xultophy next month, with a decision on IGlarLixi now pushed out to the end of November.

The amount paid for the voucher reveals the importance attached by Sanofi being first to market in the US with IGlarLixi, which is viewed as an important revenue generator now that $8bn-a-year blockbuster Lantus is facing biosimilar competition in some markets.

Novo Nordisk's drug was first launch in Europe early in 2015 and at last count was available in six countries, while Sanofi only filed for EU approval of IGlarLixi in April. In its second-quarter results statement released earlier this month Novo Nordisk said the Xultophy roll-out was proceeding as expected, although it did not break out any individual sales figures for the product. 

That reticence is likely due to the company's decision to withhold the product from the German market after failing to get favourable pricing, which will have impacted growth.

Commenting on the delay, Sanofi has already submitted the requested data to the FDA but said this represents a "major amendment" to the marketing application. 

With a positive FDA advisory committee vote in May, the company had been planning to launch the product within a couple of weeks of an end-August approval.

However, at the time panellists said they had concerns about the SoloStar pen injector used in IGlarLixi, and in particular that the use of two separate injectors for delivery could lead to dosing errors.

Article by
Phil Taylor

22nd August 2016

From: Regulatory

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