FDA accepts NDA for Xeris’ Glucagon Rescue Pen – October 23, 2018
Xeris today announced that FDA has accepted its New Drug Application (NDA) for the Glucagon Rescue Pen – a ready-to-use, liquid-stable glucagon autoinjector – and assigned a Prescription Drug User Fee Act (PDUFA) date of June 10, 2019.
Importantly, this represents the first acceptance – to our knowledge – of a next-gen glucagon for regulatory reviewal. Neck-and-neck with Xeris’ product is Lilly’s nasal glucagon, which was submitted to FDA and EMA along a similar timeline to the G-Pen (~2Q18). That said, it’s certainly possible that FDA has accepted Lilly’s NDA as well, and the company hasn’t made an announcement; on the other hand, the more novel administration method of nasal glucagon may be taking FDA a bit longer – we expect to know more when Lilly reports on November 6.
We don’t anticipate any big regulatory hurdles, given that both products have demonstrated non-inferiority to current standard-of-care and don’t carry any excess/additional safety issues or concerns. In the case of an Advisory Committee meeting, we would anticipate a significant patient advocacy presence.
To be sure, both Xeris’ G-Pen and Lilly’s nasal glucagon offer massive improvements over current glucagon reconstitution kits, which are unwieldy and error-prone, requiring a complex and time-consuming mixing process. For example, in one human factors study, 99% of participants successfully administered a full glucagon dose with the G-Pen compared to only 6%-31% of those using reconstitution kits, reflecting the potential for the G-Pen to offer a real-world benefit on safety.
We strongly hope that more user-friendly products will expand both access to and uptake of emergency glucagon, which we understand to be heavily under-prescribed and under-distributed. As Xeris has stated, only ~50% of type 1s and ~3% of type 2s with a mealtime insulin prescription also fill a glucagon prescription.
–by Peter Rentzepis, Ann Carracher, and Kelly Close