As Novo Nordisk hustles up an oral version of its GLP-1 diabetes drug Ozempic for FDA review, the big Eli Lilly competitor has posted another positive late-stage piece of the data puzzle for its rival to Trulicity.
Novo posted a positive profile for its Phase IIIb study combining Ozempic (the injectable semaglutide) with an SGLT-2 drug, comparing it with SGLT-2 plus a placebo. The magic number in this field is an A1C number of 7% or less. Starting with a mean baseline number of 8%, the Ozempic combo cut AIC by 1.5% compared to 0.1% for a placebo — which doesn’t say much for SGLT-2.
That met the primary endpoint with a highly significant p<0.0001. A significant 78.7% of the combo arm hit the goal versus 18.7% in the control arm. And the secondary on weight loss hit as well: 4.7 kg vs 0.9 kg.
Novo Nordisk has a focused R&D group that’s been shaking up its organizational structure in the past year or so. It’s also concentrated resources around the Ozempic brand in a determined effort to build blockbuster sales in a field where marginal advantages can pay off handsomely. EvaluatePharma has pegged franchise revenue at $4.25 billion, just behind the leader’s $4.9 billion forecast.
R&D chief Mads Krogsgaard Thomsen boasted: “These data further reinforce the results from across the SUSTAIN clinical development program and the benefits of Ozempic that clinicians from many countries are already seeing in their day-to-day practices.”
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