FDA approves Novo Nordisk’s Fiasp (faster-acting aspart) the second time around – September 29, 2017

Novo Nordisk just announced the FDA approval of next-generation mealtime insulin Fiasp (faster-acting insulin aspart). This regulatory decision comes right in time with the expected 3Q17, following a Class II resubmission in March 2017. The FDA issued a Complete Response Letter (CRL) for the company’s initial New Drug Application (NDA) last October, citing concerns with the immunogenicity and pharmacology assay for faster-acting insulin aspart – we expect all these questions have been addressed through the resubmission, and we’re beyond happy that a more advanced rapid-acting insulin option will soon be available to people with type 1 and type 2 diabetes in the US. Stateside launch is slated for late December 2017 or 1Q18.

Adding to our excitement, we learned from Novo Nordisk that Fiasp will be priced on par with NovoLog in the US. This follows the company’s cost strategy in the UK and other geographies, but we think it’s an especially smart and important decision for the US market, given the tough pricing environment surrounding insulin in particular and diabetes drugs in general. Of course, it will also be up to PBMs and payers to offer strong reimbursement for Fiasp, which we imagine could be cost-saving over the long term due to fewer hypoglycemia events and tighter glycemic control (more on this below). We’d love to see real-world data collection start right away to support these prospects for cost-saving. Given the benefits to faster-acting insulin aspart over its predecessor, we very much hope for broad patient access.

• In the phase 3 Onset program, Fiasp demonstrated superior A1c-lowering and improvements in postprandial glucose excursions vs. Novo Nordisk’s NovoLog (insulin aspart), all without increasing risk for hypoglycemia. While some have interpreted these results to show incremental rather than disruptive benefit between current and next-gen prandial insulins (at least in comparison to the big jump between Lantus and next-gen basal insulins Toujeo and Tresiba), we continue to believe that Fiasp’s faster onset/faster offset will meaningfully improve quality of life for so many people with diabetes. This product holds potential to reduce uncertainty around meals and to mitigate fear of hypoglycemia, which could lead to substantially better glycemic control for real-world patients. After all, data indicates that 79% of type 1 patients and 58% of type 2 patients lower their insulin doses following a severe hypoglycemia episode (leading to suboptimal glycemic control), and that 72% of PCPs and 79% of diabetes care specialists would treat hyperglycemia more aggressively if fear of hypo wasn’t a factor (once again, leading to suboptimal glycemic control). What we had before to bolus was simply not good enough, and we think this FDA-approval of the first next-generation rapid-acting insulin is something to celebrate. Anyone who says the improvement is “incremental” dismissively doesn’t understand people who have diabetes and take mealtime insulin.
  
  • Other ultra-rapid mealtime insulins on the competitive landscape include a phase 3 candidate from Sanofi (study currently recruiting and expected to complete January 2019 according to ClinicalTrials.gov) and phase 2 candidates from Adocia and Lilly. MannKind’s inhaled insulin product Afrezza is pending an FDA decision on an ultra-rapid-acting label claim (also expected by the end of 3Q17).
• Moreover, Fiasp could stimulate growth for the rapid-acting insulin class, which has posted sluggish sales in recent quarters. Year-over-year (YOY), whole class revenue was down 7% in 1Q16, up a modest 1% in 2Q16, down 6% in 3Q16, down 2% in 4Q16, up 14% in 1Q17, and up another 1% in 2Q17. Individual sales trends for NovoLog and Lilly’s Humalog (insulin lispro) reflect similar commercial challenges – a tough US pricing environment, as well as increasing competition from SGLT-2 inhibitors and GLP-1 agonists, which address postprandial glucose excursions – while Sanofi’s Apidra (insulin glulisine) has never quite taken off commercially. In 2Q17, NovoLog captured 50% of this market by value. Humalog accounted for 43% of pooled sales, while Apidra accounted for 7%, by our calculations. We’ll be curious to see how Fiasp affects these dynamics now that it’s approved for the US (the largest diabetes market globally), and we look forward to commentary from Novo Nordisk management to this end on the company’s 3Q17 earnings call, scheduled for November 1. Hopefully, we’ll also hear more details on the planned US product launch.
• Fiasp was EMA-approved in January 2017, and has also launched in Canada.

-- by Payal Marathe and Kelly Close