The U.S. FDA has delivered another twist in the race to win approval for an insulin-GLP-1 agonist combination product. Having handed the lead to Novo Nordisk ($NVO) last month by delaying a decision on Sanofi ($SNY) and Zealand Pharma’s (CPH:ZEAL) hopeful, the FDA has now reordered the field once again.
The latest action sees FDA punt its decision on Novo’s IDegLira back by three months, resulting in the Danish drugmaker having to wait until December before it learns its fate. By then, the FDA should have made a decision on whether to approve IGlarLixi, the insulin-GLP-1 agonist combination drug Sanofi and Zealand are developing as a rival to IDegLira. The FDA is set to make a decision on IGlarLixi by the end of November.
In a brief statement to disclose the news, Novo said the FDA delayed its decision to give it enough time to complete its review of IDegLira. Novo filed for approval one year ago, before going on to receive the backing of all 16 members of an FDA advisory committee that voted on whether to recommend the drug for approval in May. At that time, IDegLira looked positioned to win approval in September, setting Novo up to scrap with Sanofi for market share.
That scrap may still happen, but it will start later than expected. The FDA delayed its decision on Sanofi and Zealand’s drug by three months in August. That decision was intended to enable Sanofi to submit more information on its drug delivery device, the merits of which were scrutinized by the advisory committee. The delay appeared to nearly wipe out the advantage Sanofi gained by playing its $245 million (€220 million) priority review voucher, but the setback to Novo has reinstated its edge.
While Zealand was transparent about the causes of its delay, Novo has been less forthcoming about why the FDA needs another three months to review its application. The briefing document released by the FDA flagged several areas of concern for the regulator--notably potential bias in a trial comparing IDegLira to Tresiba--although none of the committee members saw them as serious enough to justify voting against the drug.
Whatever the reason for the delay, it means IDegLira will, at best, be finding its feet as a commercial product--and may be playing catch-up against IGlarLixi--when Lars Fruergaard Jorgensen takes over as CEO of Novo in the new year. Analysts have pegged IDegLira as a potential blockbuster, making it an important prospect for Novo at a time when the company is trying to grow in the face of generic competition and pricing pressure.