Results

Novo Nordisk’s ‘sema’ whips Merck’s diabetes drug rival in PhIII as it reaches for best-in-class ranking for GLP-1 group

Novo Nordisk keeps racking up stellar results from its late-stage slate of trials testing the full potential of oral semaglutide in treating diabetes. And the work is drawing some wide-ranging applause from analysts who believe the Danish biotech is on a clear course to mega-blockbuster status, at the expense of its rivals.

The results today are from Pioneer 4 and 7, demonstrating superiority over its own Victoza as well as Merck’s Januvia. As for the injectable GLP-1 Victoza, there was a match on blood sugar and a beat on weight loss, which will tip the scales in its favor. As for Januvia, oral sema beat it on both scores, giving Novo the win across the board.

“Novo now has an oral GLP-1 which is at least as good (if not better) than Victoza on A1C and weight loss … but orals trump injectables – thereby making it a very compelling offering,” noted Evercore ISI’s Umer Raffat. “In a second trial, the efficacy profile held up vs Januvia with twice as much A1C control and 2+ kg weight loss beyond what Januvia produced.” 

This is why Deutsche Bank is pegging semaglutide as a $5 billion drug, making it a key part of Novo’s pipeline as the majors slug it out for market share.

Novo’s shares $NVO surged 4% on the encouraging news.

The study’s bottom line on the data:

— When applying the secondary statistical approach for week 26 and week 52, respectively, people treated with oral semaglutide experienced a reduction in HbA1c of 1.3% and 1.2% compared to 1.1% and 0.9% with Victoza® whereas placebo declined by 0.1% and increased by 0.2%…. the American Diabetes Association (ADA) treatment target of HbA1c below 7.0% was achieved by 69% of people treated with oral semaglutide, 63% of people treated with Victoza and 18% of people treated with placebo after 52 weeks; the difference between oral semaglutide and placebo was statistically significant.

— (P)eople treated with oral semaglutide experienced a statistically significant reduction in HbA1c of 1.4% compared to 0.7% with sitagliptin (Januvia) at week 52. From a baseline HbA1c of 8.3%, 63% of people treated with oral semaglutide achieved the target HbA1c below 7% after 52 weeks of treatment compared to 28% of people treated with sitagliptin, and the difference was statistically significant. The reduction in body weight of 2.9 kg with oral semaglutide was statistically significantly greater at week 52 compared to 0.8 kg with sitagliptin.


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