The FDA has delivered a setback to Sanofi ($SNY) and Zealand Pharma (CPH:ZEAL) days before it was due to make a decision about their Type 2 diabetes drug IGlarLixi. The regulator is demanding more information on the drug delivery device, pushing back the PDUFA date and nearly wiping out the time Sanofi saved by redeeming a $245 million (€216 million) priority review voucher.
Sanofi and Zealand were 8 working days away from an FDA decision date when they revealed the regulator had pushed their PDUFA date back by up to three months. The delay, while short, means Novo Nordisk ($NVO) now has a lead in the race to bring an insulin-GLP-1 agonist combination product to market in the U.S. Sanofi showed how much a few months mean to its flagging diabetes franchise when it used its $245 million priority review voucher to shave four months off the approval process for IGlarLixi.
The FDA’s request for more information means that gamble won’t have the desired effect. Having won the 16-0 backing of an FDA advisory committee vote by in May, Novo’s IDegLira is on track to receive FDA approval in the coming weeks. In contrast, Sanofi and Zealand are now thinking of the timeline in terms of months, not weeks. The new PDUFA date is set for the end of November, close to when Sanofi would have received a decision had it not redeemed its priority review voucher.
On the surface, the plan appeared to have worked until this weekend. Sanofi filed its NDA three months after Novo, but the advisory committee meetings for IDegLira and IGlarLixi took place within days of each other. Sanofi fell short of the clean advisory committee sweep achieved by Novo, but, with the panel voting 12-2 in favor of IGlarLixi, it looked to be in a strong position to pip its rival to the post in the race to bring a insulin-GLP-1 drug combination to Type 2 diabetics in the U.S..
With hindsight, the FDA briefing document and the reasoning of the dissenting advisory committee voters were littered with hints that IGlarLixi could hit a roadblock down the line.
One of the two "no" voters, MedStar Washington Hospital Center's Ken Burman, attributed his decision to concerns about the delivery pen used by Sanofi. The FDA flagged up its own concerns with the pen in its briefing document, in which it said the proposed delivery system is “complicated,” “not intuitive” and could “lead to use and dosing errors.”
Now, three months after the FDA wrote those words and Burman cast his vote--and days before a final decision was due--the regulator has asked Sanofi to provide updated information on the delivery pen. As the additional information represents a major amendment to the NDA, the FDA has pushed back the PDUFA date by three months, meaning it should now make a decision on Novo’s IDegLira before IGlarLixi.
Shares in Zealand traded down more than 6% in early trading in Copenhagen.
- read the release
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