Novo Nordisk’s new ultrafast-acting insulin got sidelined by the FDA last year, but the drugmaker is launching it in markets in Europe and elsewhere as it seeks to boost its fortunes in the face of heightened U.S. payer pressure.
Following a January approval in the EU, Novo introduced fast-acting insulin aspart, Fiasp, in the U.K. this week, according to The Pharma Letter (sub. req.). The rollout followed earlier pushes in Germany and Canada for the “ultra-fast rapid-acting insulin” that trials show more closely mimics the body’s natural insulin production.
Novo has launches throughout Europe planned for the first half of this year, the company said in an earlier statement about the EU approval. It's filed for approval in several other countries including the U.S.
The drugmaker received an FDA complete response letter last year relating to its U.S. application. The regulator wanted to see more immunogenicity and clinical pharmacology data before completing the review.
Last week, after Novo resubmitted its med in the U.S., Bernstein analyst Ronny Gal wrote in a note that the FDA is expected to act on the med by this year's fourth quarter. He called Fiasp an "important product for maintaining the short-acting insulin franchise." Gal has previously predicted a 2018 launch for the insulin in the U.S.
The Fiasp rollout comes at a tough time for the Danish drugmaker, which cut 1,000 employees loose last fall due to unprecedented payer pressure in the U.S. That squeeze continues to whittle away at Novo’s key diabetes business as payers force deep discounts in order for drugmakers to secure access to their formularies.
Novo’s restructuring hit its R&D and commercial operations as the company shifted its focus to innovative new products.
With Fiasp, it’s offering a product that brings “incremental benefits … comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago,” Chief Science Officer Mads Krogsgaard Thomsen said in a release.
In the U.K., Fiasp will be covered through NHS England, according to The Pharma Letter.
Aside from all of the damaging payer pressure, Novo also faces calls for an investigation into alleged insulin price fixing with Sanofi and Eli Lilly, and a class-action suit relating to those allegations.