R&D, Results

Building on impressive data, Novo Nordisk maps big PhIII obesity program for blockbuster hopeful semaglutide

Encouraged by evidence of the impact that its diabetes drug semaglutide can have on obesity, with patients shedding an average of 16% of their weight in a mid-stage study, top researchers at Novo Nordisk today unveiled an ambitious late-stage strategy to make their mark in a tough, but potentially blockbuster market.

In an R&D update during its Capital Markets Day at its HQ near Copenhagen, investigators for the company said they will recruit 4,500 patients for a Phase IIIa obesity trial for semaglutide, a GLP-1 drug now up for a likely near-term approval at the FDA. And they plan to launch the 68-week study next year, alongside a “landmark” cardiovascular outcomes study with 12,500 people enrolled.

Peter Kurtzhals

Building on what they already know about the drug from a recently wrapped mid-stage study, Novo believes it has excellent prospects fielding a drug that can knock off 15% or more of a person’s weight — significantly better than the last wave of therapies to hit an anemic market ruled by skepticism for the minimal results seen in the data. Researchers also told investors in Denmark that the company believes it can move that mark up to 25%-plus of an obese person’s body weight by using some biologic combos it has in mind. And that would put it in the same league with surgery.

“Maybe 25 percent (weight loss) or beyond, but we start by setting the bar at 15 percent or beyond,” senior vice president of global research Peter Kurtzhals told a group, according to Reuters.

Novo Nordisk plans to launch the drug first in diabetes, after posting data demonstrating its ability to beat out Eli Lilly’s Trulicity. Just a few weeks ago an FDA panel of outside experts voted almost unanimously to endorse semaglutide, to be marketed as Ozempic, likely setting up a near-term approval for one of this year’s top blockbusters in the pipeline.

Analysts have pegged its potential sales revenue at more than $2 billion in 5 years.


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