With FDA delay, Sanofi loses head start in diabetes combo-med rivalry with Novo

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Sanofi spent $245 million on a priority review voucher to beat Novo Nordisk to market with a diabetes med pairing a basal insulin with a GLP-1. But the FDA had other ideas.

After that fast-track review, the agency pushed Sanofi’s Lantus-plus-lixisenatide combo off till November at the least. The FDA asked Sanofi for more data on the dual-drug delivery pen--a device that triggered debate during an FDA advisory panel review in May.

With an FDA decision on Novo’s product due next month, the unexpected Sanofi delay could give the Danish drugmaker more than two months’ head start. In today’s high-stakes fight for diabetes market share, any advantage--first mover or otherwise--could make a significant difference for a drug launch.

Sanofi has already submitted the additional information for its new combo, the company said in a release late Friday. The company “appreciates the feedback from the FDA on the delivery device and believes that the information submitted will result in an offering that will serve the needs of adults living with type 2 diabetes in the U.S.,” Sanofi said. 

The FDA’s expert panel had raised questions about trial data suggesting that a number of people had trouble using Sanofi's pens. But the committee members also generally agreed that LixiLan offered a convenient new weapon against diabetes, and voted 12 to 2 in favor of approval. At the time, analysts believed that the panel’s questions were not significant enough to delay LixiLan’s approval.

Novo’s drug, Xultophy--which pairs its recently approved, longer-acting basal insulin Tresiba with its GLP-1 blockbuster Victoza--won unanimous backing from the same panel.

Xultophy is approved in Europe but not in the U.S., where a delay on Tresiba held up plans for filing the combo. Sanofi's idea was to beat the Novo combo product to the U.S. market and gain traction ahead of a Xultophy launch. It saw the head start as so important that it used that pricey priority review voucher to cut review time at the agency.

It’s not all about timing, of course. The two companies have been racking up data and crafting their arguments for a head-to-head rivalry as pricing pressure slows growth in the overall diabetes category. Sanofi, for its part, unveiled two LixiLan studies at the American Diabetes Association meeting in June, showing that the combination beat each of its ingredients on its own at controlling blood sugar.

Plus, patients on the combo lost weight or, at the least, saw no change in weight, Dr. Rachele Berria told FiercePharma at the time. Weight gain is a key side effect of basal insulin. To add to its evidence, the company is planning a head-to-head trial of LixiLan in another group of patients: those who still struggle with their blood sugar levels even with treatment with a GLP-1.

"We think this drug will have an impact on many patients struggling with diabetes," Berria said.

But Novo’s combo may have a couple of advantages. Analysts figure that Xultophy may be approved with a broader label than LixiLan’s, giving Novo a bigger patient population to target. More importantly, Victoza now sports outcomes data showing that it cuts cardiovascular risks, where lixisenatide does not. Novo’s much-anticipated LEADER trial found that the GLP-1 med cut the risk of CV death by 22% and reduced overall cardiovascular risks by 13%. In its own outcomes trial, Sanofi’s drug did not increase cardiovascular risks, but did not reduce them, either.

But Xultophy is anticipated to be expensive, because Victoza is expensive. And this is where LixiLan might find an advantage. Sanofi could “primarily view the drug as a protection mechanism for Lantus and will price it at modest price increase to the single agent Lantus, creating pricing pressure on the category,” Bernstein analyst Ronny Gal said in an investor note.

Leerink Partners forecasts about $5 billion in peak sales for Xultophy and $1.5 billion to $2 billion for LixiLan.

- read the release from Sanofi

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