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SAN FRANCISCO – Novo Nordisk may have already submitted its application for approval for its oral drug GLP-1 semaglutide, but the deluge of positive data has not stopped.
Tuesday, at the annual meeting of the American Diabetes Association, the Danish drug manufacturer presented the cardiovascular results showing that its expected blockbuster did not affect cardiovascular safety in patients with type 2 diabetes at high risk.
RELATED: Novo Nordisk feeds the hope of GLP-1 while weekly semaglutide reduces heart risks by 26%
The study was not intended to show that the drug could confer cardiac benefits, unlike those of the GLP-1 class of semi-glutide. And that's because Novo already has data showing that an injectable version of the compound, already marketed as Ozempic, could reduce the combined risk of heart attack, stroke and cardiovascular death by 26%.
"Once it gets into the blood, it's the same molecule," said Todd Hobbs, Novo's US medical officer, who hopes to have both sets of data on the oral semaglutide label. "Taken together, we really hope this is favorable" in the eyes of prescribers, he said.
Earlier in the meeting, Semaglutide continued its research on the already marketed anti-diabetic products, publishing more data in confrontation – this time in one year – against SGLT2 market leader, Jardiance of Eli Lilly, and Boehringer Ingelheim GLP-1 generation, Victoza.
In a study dubbed Pioneer 2, the candidate was still ahead of Jardiance in terms of reducing the HbA level, a common measure of blood glucose, at 52 weeks. And in Pioneer 4, he achieved the same feat against Victoza and placebo in one year, registering a 1.2% drop from the 0.9% mark of the old drug and the 0 mark, 2% of the placebo.
"When you look at all the Pioneer studies of the cascade of treatments, even from the beginning to the addition of insulin, it's really a good message that it is superior and has a very good profile in all these areas. studies, "said Hobbs.
With this kind of results, Novo hopes to see a move from primary care physicians who have not yet taken the GLP-1 train. Right now, they "do not really adopt GLP-1s perhaps as they should with the guidelines supporting their use," Hobbs said. "What we hope is primary care physicians in particular who are not comfortable with injectable GLP-1" will "adopt GLP-1 orally".
RELATED: Novo has a big price to decide with semaglutide. Where will he go?
Of course, the speed with which oral semaglutide will be adopted once approved will depend on Novo's prices, subject to many speculations among industry observers for years. And although Hobbs said the company did not set a price, she "was doing everything possible" to work with the payers in the meantime.
"We absolutely want to make it competitive," said Hobbs, noting that the price of the drug "will not necessarily be considered a small molecule price."
"We absolutely want to make sure that access is not an obstacle," he added.
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