Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow
Earlier this month, the small French biotech Inventiva touted themselves as having won the first FDA breakthrough designation in NASH since Intercept grabbed the first one back in 2015, before the disease had become one of biotech’s hottest areas. Unbeknownst to them, though, a much larger European rival had already landed the status months prior.
Novo Nordisk, the Danish metabolic giant, disclosed in their Q3 report Friday that back in August, the FDA gave them breakthrough status for semaglutide, their blockbuster diabetes drug, in NASH, or non-alcoholic steatohepatitis. The designation sets Novo up as a leading contender in a new wave of companies developing treatments for a silent and widespread disease that, despite a series of setbacks, is still viewed by many as a huge potential market.
As with Inventiva, the status came on the heels of positive results in a Phase II trial. Back in their Q1 — some companies have a habit of burying negative news deep in SEC filings, Novo seems to have a habit of burying good news — the Big Pharma revealed data from a 230-person study, showing that those who received any of 3 doses of the drug were significantly more likely than a placebo arm to see their NASH resolve without their fibrosis worsening. On the high dose, 33 out of 56 patients achieved resolution, compared to 10 out of 58 on placebo.
Novo said today they plan to launch a Phase III trial next year. It’s a stage where other big NASH drugs have gone to die, although not all had shown clear results in Phase II. Gilead didn’t run a placebo-controlled Phase II study prior to their Phase III stumbles, and Genfit’s drug had failed a Phase II before it failed its Phase III.
At the moment, it’s not clear what bar Novo — or Inventiva or NGM — would have to clear in a Phase III trial to gain approval. Relying on their reading of guidance from the FDA, Intercept filed for approval after a Phase III in which they showed the drug could improve fibrosis but didn’t show it could resolve NASH. The FDA, however, rejected the pitch.
A NASH approval would represent another expansion on a GLP-1 drug that has already reaped billions for Novo Nordisk, taking in $1.64 billion last year in sales. The company is also planning to expend a priority review voucher on an application in obesity.