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Posted On: 11/02/2020 12:46:52 AM
Post# of 154804
Novo Nordisk gets 'breakthrough' status in NASH
Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow
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.
Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow
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.
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