FDA accepts NDA for Xeris’ Glucagon Rescue Pen


#1

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


#2

would love to see pricing. My guess is that many insurances aren’t going to pay the lion’s share of the cost of this stuff, just like many don’t already make it easily affordable to buy currently-marketed Glucagon kits. I hope to see the day when this stuff is not marked up so much and that insurance will cover it better (one goes hand in hand with the other). I’m dreaming, I know.


#3

@Dave44 - The company has more products in the pipeline. The G-Pen is the closest to market. Assuming they are successful in bringing the same drug to market for other purposes, they would have the potential to scale up and reduce costs.

Time will tell.

Obviously other companies move in the other direction but that is no guarantee of what this company will do.


#4

XERIS PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF NDA FOR ITS READY-TO-USE GLUCAGON RESCUE PEN

If approved, the Xeris glucagon rescue pen would be the first ready-to-use, room-temperature stable liquid glucagon in an auto-injector to treat severe hypoglycemia

Robust clinical trial results from multiple Phase 3 studies and Human Factors studies demonstrating safety and efficacy in emergency settings support the NDA PDUFA goal date of June 10, 2019

CHICAGO, IL; October 23, 2018 – Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that its new drug application (NDA) for its ready-to-use, room-temperature stable liquid glucagon rescue pen for the treatment of severe hypoglycemia in people with diabetes has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of the glucagon rescue pen NDA of June 10, 2019.

“The FDA acceptance of our NDA for review, is an important milestone for Xeris. If approved, the Xeris glucagon rescue pen would be the first ready-to-use, liquid-stable glucagon in an auto-injector to treat severe hypoglycemia. Compared to the current glucagon rescue option for people with diabetes who are at risk for severe hypoglycemia, the Xeris glucagon rescue pen would eliminate the need for reconstitution and dramatically simplify the preparation and administration process,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “We believe that our glucagon rescue pen has the potential to make an important difference in the lives of people with diabetes.”

The 505(b)2 NDA is based on positive results from multiple Phase 3 clinical trials of the efficacy, safety, and utility of the Xeris glucagon rescue pen auto-injector in treating severe hypoglycemia when compared with currently marketed glucagon emergency kits among adults, children and adolescents with type 1 diabetes (NCT02656069, NCT03091673, NCT03439072). Key study results illustrating the efficacy and tolerability of the glucagon rescue pen for both adults and children with diabetes were presented during the 78th Scientific Sessions of the American Diabetes Association (ADA), June 22-26, 2018.

In addition, positive data from Human Factors usability and reliability studies demonstrating the functional efficacy of the Xeris glucagon rescue pen supported the NDA submission. The results of one of these studies were presented during the Advanced Technologies and Treatments for Diabetes (ATTD) conference in February 2018.


#5

the problem with that (scale up and reduce costs) theory is that historically, low costs don’t often translate to low prices. Look at Apple, Dyson, pharma, cosmetics…many products that are made for pennies or a relative few dollars, remain priced very high using the age-old method of “what the market will bear”. Corporations don’t have consciences–they have shareholders or greedy owners. this will NEVER change–it’s human nature.


#6

@Dave44 - Agreed.

I still have hope.

:stuck_out_tongue:


#7

This is made up nonsense - concocted out of thin air IMHO I could get 100 people off the street and more then 3 of 10 would do it correctly - nevermind 6 out of a 100.

Complex and time consuming - no bias there

How is putting fluid into a vial and withdrawing it COMPLEX?

I defy them to repeat the study in the real world - not fantasy land

And why is it necessary to attack the kits - Maybe their product can not stand on it’s own merits.


#8

I think it’s complex for anyone who hasn’t been previously trained in how to do it and/or hasn’t practiced with an expired glucagon kit. Most people have never handled a syringe in their lives, much less reconstituted and delivered a medication.

Plus, the person trying to administer the glucagon is also dealing with an unconscious friend, colleague, or family member. Even when previously trained and fully competent, that kind of stress can seriously affect someone’s ability to think clearly, remember the order of steps, and perform fine-motor tasks.


#9

I did it at 3AM - waking out of a dead sleep having never even opened the container previously - with my wife unconscious

I call BS - plain and simple to the study


#10

I’m sorry to hear you had that experience and am glad you were able to handle it well.

But just because you were able to handle it well means that you were able to handle it well, nothing more.

You can’t just call a study BS because you don’t like its conclusions. Go read the peer-reviewed study and debate its methodological merits, sure. But don’t just read an article about a study and say it’s BS because you happened to have a difference experience.


#11

I am not calling it BS because I did it

I am calling it BS because 6 to 31 percent - really??

Which is it 6 or 31

I simply don’t believe it - that’s it

I would bet body parts this cannot be replicated in front of me if those conducting it are willing to do the same


#12

It could be both. We don’t know the study design. There could have been more then one group.


#13

Well, since you asked: My wife at the time, bent the needle of the glucagon syringe because she was so nervous as we had just rushed (breaking traffic laws along the way) home from a restaurant about 1.5 miles from the house when I realized I had accidentally injected more than 20U of Regular & Lente into a leg vein/artery and was dropping like a rock. By the time we got home my bg must have been just a few points above zero and I was about to pass out. She was so nervous she missed the correct spot on top of the vial. Despite being nearly blind from super-low blood sugar (out of breath, heart pounding like never in my life, and shaking uncontrollably) , I grabbed it from her and managed to quickly reconstitute and stab myself in the belly with the glucagon. Within 3 minutes or so, the paramedics got to me and hooked me up to an IV. By the time I got into the amblulance I was well over 300. things can happen very, very fast.

The only reason I was able to get the glucagon into me despite my current physical symptoms, I did it because I KNEW I was going to die if I didn’t accomplish it. The will to live is quite strong here. It’s quite a feeling to know that you are just seconds away from passing out and it could be your final conscious thoughts. scary stuff.


#14

You did good - happy ending

Bending the needle can happen to anyone - even those who have done it numerous times

My point is the numbers they published - 6-31 are ridiculously low


#15

Just personally I feel like I’d be much more confident having someone quickly injecting something into me rather than trying to get me to inhale something if I were disabled/unconcscious. Either way has got to be better than the current rube-goldbergian approach. It’s high time that old kit thing was consigned to the dustbin.


#16

Even though I have walked my wife through the steps, I know that she would be FAR more comfortable with this setup!
It will most likely cost too much, and not come down in price.
UNLESS they start making more glucogen for the newer pumps that use both glucogen and insulin. That might make this part of the equation less expensive.
But until is isn’t seen as an ‘emergency only’ kind of thing, I doubt the price will go below anything that is considered ridiculous.


#17

Exactly. As my wife put it: “You know, if you’re passed out on the floor at 3am and I get out of bed all bleary-eyed and really have to do this, I’m not sure what’s going to happen.”


#18

Have her practice with an expired one


#19

Or not have to, which would be better.


#20

Good point - they could certainly make bigger type

anyone with any vision problems is going to have a hard time.