fiercepharmaJuly 02, 2018
Tag: Januvia , Novo Nordisk , Diabetes , Oral Semaglutide
Just eight days after posting a trial win over Merck diabetes stalwart Januvia, Novo Nordisk candidate semaglutide is back with another.
Thursday, the Danish drugmaker said that in a phase 3a trial, its wannabe blockbuster, a once-daily oral GLP-1 med, had outdone Merck’s DPP-4 drug at the 26-week mark. Semaglutide topped Januvia at reducing HbA1C, an important measure of blood sugar control, and patients in the semaglutide arm also lost more weight than those in the Januvia arm, the company said.
The results follow closely after those from a head-to-head between the two drugs in which Novo aimed to simulate a real-world setting. In that study, 63% of patients receiving semaglutide achieved target HbA1C levels of below 7% after 52 weeks of treatment, while just 28% of patients in the Januvia arm accomplished that feat.
Novo already has a mountain of evidence supporting semaglutide’s safety and efficacy—along with an approval for a once-weekly injectable formulation of the drug, currently launching under the commercial name Ozempic. And all eyes are on the prospect, with industry watchers expecting it to shake things up within the diabetes landscape.
Which drugs are at greatest risk once oral semaglutide hits the scene? DPP-4s such as Merck's Januvia, one expert told Credit Suisse analyst Vamil Divan after last weekend’s American Diabetes Association annual meeting. "He sees the clinical profile of oral sema along with the convenience of oral dosing as being very compelling and likely most negatively impacting the DPP-4 class," Divan wrote in a Wednesday note to clients.
But other GLP-1s could feel the heat, too. Eli Lilly’s Trulicity, which recently steamrolled its way past the 40% market-share mark, is one of them.
The Indianapolis drugmaker’s executives, though, say they aren’t worried—especially if Novo positions semaglutide earlier in treatment, where it’ll have to contend with Lilly’s heart-helping SGLT2 treatment, Jardiance.
"We look at the value proposition of a Jardiance, for example, which is going to be difficult" for semaglutide to match, diabetes head Enrique Conterno told investors on Lilly’s fourth-quarter conference call earlier this year.
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