Memorandum
Novo Nordisk announced this morning that the EMA has granted a marketing authorization for Fiasp (faster-acting insulin aspart), effectively approving the next-generation prandial insulin for marketing and sale in Europe. According to the company announcement, Fiasp will be launched in the first EU countries in 1H17 and will be available in a vial, Penfill, or FlexTouch pen. The drug previously received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) – always an extremely good sign for a product’s chances at EMA approval – and was approved by Health Canada last week. Fiasp is still awaiting a regulatory decision in the US, Switzerland, Australia, Brazil, South Africa, and Argentina. We haven’t heard any updates from the company on the US timeline since the FDA’s very surprising Complete Response Letter (CRL) for Fiasp in October 2016, but we’re hopeful that with amendments to the application, faster-acting insulin aspart will be available in the US in the near- or mid-term future. Faster-acting prandial insulins that better mimic physiologic post-meal insulin action would certainly be welcome. That said, based on phase 3 data, our sense is that Fiasp represents closer to an incremental rather than truly disruptive advance compared to the advantages offered by next-generation basal insulins (Novo Nordisk’s Tresiba [insulin degludec] and Sanofi’s Toujeo [U300 insulin glargine]) over first generation basal insulin analogs. Nonetheless, we’re excited to see this first next-generation rapid-acting insulin reach the commercial market – needless to say (we hope), we’ll very much take incremental improvements compared to nothing given that the current offerings still create significant hypoglycemia and weight gain for those who would benefit from even an incremental improvement. Questions on price and access remain, but for now, we are extremely happy to see the expansion of patient choice in the prandial insulin space.
-- by Payal Marathe, Helen Gao, and Kelly Close