The FDA has demanded more information on the delivery device for a type 2 diabetes drug called iGlarLixi from Sanofi SA (NYSE:SNY). This has led to a delay of the drug, thus causing a huge setback on the company’s timeline.
This is bad news for Sanofi because it has redeemed a $245 million priority review voucher for a specific timeline which it had set to beat Novo Nordisk (NYSE:NVO). The FDA’s recent decision pushes back Sanofi’s PDUFA date by three months. This is bad news because it means that Sanofi will now be overtaken by Novo Nordisk in the race for introducing an insulin-GLP-1 agonist combo into the US market.
The review and approval of Sanofi’s diabetes drug were vital for the firm to the point that it redeemed the $245 million priority voucher so that it could cut down the approval process for iGlarLixi by four months, constituting a form of legal bribery to the FDA with no recourse. This means that redeeming the voucher will not have the expected impact due to the FDA’s request for more information. It is also an unfortunate situation because Novo’s diabetes treatment known as iDegLira is expected to receive FDA approval in the next few weeks. Novo also has an extra added advantage over Sanofi because it received 16-0 backing by an FDA advisory committee in May.
Sanofi’s new PDUFA date is set for November, which is just about the same time as the expected approval time had the firm not redeemed the priority review voucher. Sanofi had applied for an NDA for iGlarLixi three months after Nova’s application for iDegLira. However, the advisory committee meetings for the two drugs took place within a time difference of days rather than months. The FDA’s briefing document hinted that iGlarLixi would most likely face some bumps along the road. Sanofi recently reported that it has already submitted the additional information as requested by the FDA.