For Novo Nordisk and its new fast-acting mealtime insulin, a second try at the FDA gatekeepers was enough to secure an approval. The drugmaker's Fiasp won its U.S. nod on Friday, setting Novo up for a new launch in a crowded field.
Novo Nordisk's fast-acting insulin aspart, or Fiasp, secured an FDA green light after showing it can provide benefits for diabetes patients who need better overall glucose control, according to the drugmaker's Friday release (PDF). Bernstein analysts have predicted Fiasp will grow to over $500 million in sales by 2020.
The approval comes about a year after a regulatory stumble for the program. Last year, FDA officials issued a complete response letter on Novo's Fiasp application as they sought more immunogenicity and clinical pharmacology data. Novo resubmitted its app earlier this year and Bernstein analyst Ronny Gal previously predicted the FDA would act on the med in the fourth quarter. He's called Fiasp an "important product for maintaining the short-acting insulin franchise."
The nod comes several months after Novo launched its new diabetes medication in European countries. Back in April, Novo chief scientific officer Mads Krogsgaard Thomsen said the drug offers “incremental benefits … comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago." Studies have shown it more closely mimics the body’s natural insulin production.
On Friday, Krogsgaard Thomsen said in a statement Fiasp "allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”
But the Fiasp rollout also comes at a difficult time for the Danish drugmaker, which had to cut 1,000 employees last fall due to damaging payer pressure in the U.S. That squeeze continues to pressure Novo’s key diabetes business as payers force deep discounts in order for drugmakers to secure access to their formularies. Another diabetes giant, Eli Lilly, has reported that it's cutting 50% off of its list prices due to competitive dynamics.
Among areas hit at Novo were R&D and commercial operations as the company shifts focus to innovative new products.
Aside from all of the damaging payer pressure, Novo additionally faces calls for an investigation into alleged insulin price fixing with other top players Sanofi and Eli Lilly. The companies are fighting a class-action suit relating to those allegations.