Health Canada has approved a GLP-1 pill for the first time.
The once-a-day semaglutide pill is approved for reducing the risk of heart disease and Type 2 diabetes, the company said in a statement Monday.
Rybelsus is a glucagon-like peptide-1 (GLP-1) drug, the same type of medication as injectables Ozempic and Wegovy by the same manufacturer.
All other GLP-1 drugs available in Canada are injectables to date.
The pill has only been approved for adults with Type 2 diabetes who also have a cardiovascular disease or are at high risk for heart disease, though Novo Nordisk has applied to bring a separate pill form of weight loss medication Wegovy to Canada as well.
Novo Nordisk says its trial of Rybelsus included 9,650 patients who were randomized to receive either Rybelsus 14 mg or the placebo daily. The trial showed that the use of Rybelsus lowered the risk of cardiovascular events, like heart attacks, the company says.
The pill can work “along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes,” the Rybelsus website says.
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It can also be used to “reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus who are at high risk for these events,” the website says.
Recent research shows that the effects of GLP-1 medication end shortly after patients stop taking the medication. Weight-loss drug users, on average, regain weight at a rate of 0.4 kilograms per month after they stop taking their weight-loss medications, a review of 63 trials covering more than 9,000 individuals published in the British Medical Journal on Wednesday found.
When patients regain the weight they lost, the cardiovascular benefits of the GLP-1 drug also go away, the report showed.
That comes after the U.S. Food and Drug Administration last month approved the once-a-day Wegovy pill for weight loss.
Around two weeks after FDA approval, the oral Wegovy pill hit the market in the U.S. for the cost of US$149 a month or around US$5 a day.
However, the company warns users to check with their doctor about possible side effects before considering the medication.
While the oral pill offers convenience, that may come at the expense of effectiveness, said Dr. Fahad Razak, an internal medicine physician at St. Michael’s Hospital and professor at the University of Toronto, speaking to Global News after the U.S. FDA approved the Wegovy pill.
“The first thing that people should be aware of is that the weekly injection is a more effective means of weight loss. And for most of my patients, I would say with time and experience, they’re able to do the self-injection without too much burden,” he added.
However, he added that this might make the treatment more palatable to some patients.
“There are patients who are still very reluctant to do the weekly injection. And for those patients, the oral alternative could be something to consider. Again, not as effective, but it could be something for them to consider,” he said.
The oral semaglutide pill might come in larger doses than the injectable versions in order to make them similarly effective, said Jennifer Lake, pharmacist and assistant professor at Leslie Dan Faculty of Pharmacy at the University of Toronto.
“It’s a protein, a peptide, which means that when you take it orally, the stomach disintegrates some of it. And so that’s why it was given as an injectable in the first place,” Lake said.
However, when given orally, the drug tends to have a “relatively larger dose than we inject so that we get some through the stomach and it doesn’t get destroyed,” she added.
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