Memorandum

FDA approves Lilly’s nasal glucagon as first-ever severe hypoglycemia emergency treatment not requiring an injection – July 24, 2019

Executive Highlights

  • In a major win for the entire diabetes community, FDA announced today that it has approved Lilly’s nasal glucagon as the first-ever severe hypoglycemia emergency treatment that does not require an injection. Accompanying the approval was the reveal that nasal glucagon will be marketed under the trade name “Baqsimi.”
  • Nasal glucagon represents an enormous innovation within the glucagon landscape. Current glucagon reconstitution kits are cumbersome, time-consuming, and error-prone, as they require mixing and injecting steps that often cannot be performed by the individual experiencing the hypoglycemic event. On the other hand, Baqsimi will come in a single-use dispenser that can directly administer nasal powder glucagon without the need for preparation or injection. It’s safe to say that people with diabetes who at risk for severe hypoglycemia —namely those on insulin or a sulfonylurea — have been waiting for an alternative for quite some time. The same can be said for many of their families and care partners.

  • Lilly will reportedly market Baqsimi at the same price as its current glucagon injection at $280.80/pack, and it should be available in US pharmacies within the next month. We are curious about how COGS (cost to produce Baqsimi) differs from the COGS of traditional glucagon.

In a major win for the entire diabetes community, FDA announced today that it has approved Lilly’s nasal glucagon as the first-ever severe hypoglycemia emergency treatment that does not require an injection. Accompanying the approval was the reveal that nasal glucagon will be marketed under the trade name “Baqsimi.”

The approval of nasal glucagon represents a major step forward in both the treatment of hypoglycemia and the overall glucagon landscape. Current glucagon reconstitution kits are cumbersome, time-consuming, and error-prone, as they require mixing and injecting steps that often cannot be performed by the individual experiencing the hypoglycemic event. By contrast, Baqsimi will come in a single-use dispenser that can directly administer nasal powder glucagon without the need for preparation or injection. As a result, we see enormous potential for nasal glucagon to help patients and caregivers address hypoglycemia swiftly in everyday settings, therefore avoiding expensive hospital visits. It’s safe to say that people with diabetes and at risk for hypoglycemia—namely those on insulin or a sulfonylurea—have been waiting for this product for quite some time. We are very interested to understand a little more about the dimensions of the product and the environmental impact of a single use product, which historically people with diabetes are not particularly excited about.

As a reminder, Lilly acquired worldwide rights to nasal glucagon from Locemia in October 2015. At the time of acquisition, Locemia had already completed phase 3 studies of nasal glucagon in both adults (see coverage from ATTD 2015) and pediatrics (see coverage from EASD 2015), showing glucose-raising equivalency to injected glucagon. Real world data for nasal glucagon was also presented at ADA 2017, showing that 96% of patients experiencing hypoglycemia recovered within 30 minutes following treatment and that most of the caregivers were highly satisfied with the device. For more on the clinical trial data supporting nasal glucagon’s approval, we point to this valuable review from Yale’s Dr. Jennifer Sherr at ATTD 2018.

Very notably, nasal glucagon’s approval marks the first such approval to emerge from the next-generation glucagon landscape. Elsewhere in the landscape, Xeris has also submitted its Gvoke HypoPen (liquid-stable glucagon autoinjector) to FDA, and a decision is expected in September 2019. Zealand also has its HypoPal glucagon rescue pen (liquid stable dasiglucagon) and is targeting an early 2020 NDA submission. Lilly has also submitted nasal glucagon to EMA, and a decision is expected soon.

  • In terms of market potential, we see broad opportunity for Baqsimi and other next-gen glucagon products to experience commercial success. Lilly’s glucagon grossed $150 million in 2018, and we estimate Novo Nordisk’s GlucaGen sales to be in a similar range, although they do not officially release these results. In the past, Xeris has officially estimated US market potential for its Gvoke HypoPen at $2 billion annually based on current glucagon kit prices and a patient population of 3.5 million – this would assume the patient population is buying 2-3 glucagon kits/year. On the other hand, Zealand estimates a >$700 million market by 2025, a less ambitious estimate that still represents more than doubling from the current base of $300 million/year (a number Zealand has supplied). Regardless, it’s clear that there’s major demand for this innovation in diabetes care, and that numerous patients could benefit from nasal glucagon, along with broader education on glucagon use as a hypoglycemia treatment. Looking ahead, we hope to see manufacturers and other stakeholders leverage these innovations within the class to promote broader uptake and education within the diabetes community.

  • According to our conversations with management, we believe Lilly will price Baqsimi at the same price as its injectable glucagon. The US list price of one-pack of Baqsimi will be $280.80. We’re expecting most insurers to cover Baqsimi and are hoping to see Baqsimi be accessible and affordable for the many patients that stand to benefit from this innovation. Baqsimi will reportedly be available in US pharmacies within the next month.

KOL Comments

  • “Living with diabetes is like walking on a tight rope, but today a wider safety net is cast. With form factor differentiation between injected insulin and nasal glucagon, those who will be able to assist in the treatment of a severe hypoglycemic event has expanded drastically. For kids with diabetes, nearly 1/3rd of the day is in school, now bus drivers, teachers, and coaches will feel more confident that they can assist a student with a severe hypoglycemic event. Hopefully, the days of requests to discontinue the glucagon order for a school trip will be a thing of the past. Approval of this medication means I no longer have to tread lightly as I discuss severe hypoglycemia with new-onset families and I firmly believe that more of the prescriptions I religiously write for glucagon on an annual basis will be filled.” – Yale’s Dr. Jennifer Sherr

  • “The U.S Food and Drug Administration’s (FDA) approval of Baqsimi nasal powder is an important step toward providing more treatments to address the complications of type 1 diabetes (T1D). Severe hypoglycemia is a serious complication for people with T1D and if not treated properly it is life-threatening. Until now complex glucagon injections that take several steps to administer were the only available treatment for people experiencing a severe hypoglycemic episode. Administering nasal glucagon is a much less invasive and simplified process that can save critical moments during an emergency, particularly if an individual loses consciousness. JDRF is grateful to FDA for its decision and continues to advocate for more treatments to come to market so that people with T1D can better manage its complications and live happier and healthier lives.” — JDRF President and CEO Dr. Aaron J. Kowalski
  • "Baqsimi is a landmark, desperately-needed approval and a wonderful example of game-changing innovation focused on user experience. The human factors study comparing nasal glucagon to the cumbersome injection kit said it all: 6x as many caregivers correctly gave a full dose of intranasal glucagon in 8x less time! Terrifyingly, two caregivers in the injection group mistakenly used insulin for the hypoglycemia rescue (cleverly included in the diabetes supply bag alongside the glucagon, to simulate a realistic hypoglycemia rescue situation). Other studies have shown caregivers accidentally inject the saline alone in an emergency situation, failing to even mix it with the glucagon. In emergency scenarios, user experience is everything; finally, we have something people can use without having to decode an instruction manual.” - Adam Brown
  • "For everyone who uses insulin to care for their diabetes, the recent approval of Baqsimi, at long last, brings welcome innovation to the glucagon market. We finally have a glucagon rescue product that can be used by almost anyone to treat severe hypoglycemia. Caregivers, family members, school staff, and co-workers who wanted to help but were intimidated by the existing glucagon rescue kit can easily use Baqsimi, allowing them to help their loved ones or friends when needed." -- Children with Diabetes President Jeff Hitchcock
  • “FDA approval of nasal glucagon is a major improvement for patients who have very low blood sugar and are not able to eat/drink sugar. The only currently available glucagon must be injected and requires 7 nerve-wracking steps to use. Nasal glucagon is much simpler which will be very much appreciated by patients.” – Dr. Charlie Alexander

Baqsimi Product Photo

 

--by Martin Kurian and Kelly Close