Insulin icodec, which will be sold under the brand name Awiqli, is shown in a handout photo. Canada is the first country to get the product, which was approved by Health Canada in March for the treatment of adults with Type 1 and Type 2 diabetes.HO/The Canadian Press
Many people with diabetes in Canada will soon be able to take insulin once a week instead of daily, drug manufacturer Novo Nordisk announced on Monday.
Insulin icodec, which will be sold under the brand name Awiqli, is the first once-a-week basal insulin injection in the world and it will be available across the country starting June 30, the company told The Canadian Press ahead of the announcement.
Canada is the first country to get the product, which was approved by Health Canada in March for the treatment of adults with Type 1 and Type 2 diabetes.
“I think it’s a very big deal,” said Dr. Harpreet Bajaj, head of the clinical practice guidelines steering committee at Diabetes Canada.
“(It’s) huge for reducing the burden on these people who need to inject insulin,” said Bajaj, an endocrinologist at LMC, a publicly-funded diabetes and endocrinology specialty clinic with locations across southern Ontario and in Calgary.
He said some of his patients participated in clinical trials for Awiqli and have been asking when it would become available because they’ve had to return to daily injections since the study ended.
Although the weekly insulin has Health Canada’s approval for treatment of both Type 1 and Type 2 diabetes, endocrinologists say it will be mostly useful for Type 2 patients.
That’s largely because patients with Type 1 diabetes would still have to give themselves additional fast-acting insulin injections at mealtimes every day because their bodies don’t make any insulin on their own, Bajaj said.
People with Type 2 diabetes do make insulin, but either not enough or their bodies don’t use it properly. Basal insulin shots bring their levels of the hormone to the right amount during fasting, and other medications can control the “spikes of sugars that come with food,” Bajaj said.
The series of randomized clinical trials for Awiqli – which included many countries, including Canada and the U.S. – were mostly done with Type 2 patients. Only one of the trials involved patients with Type 1 diabetes and found a higher risk of low blood sugar when those patients took the weekly insulin option.
The U.S. Food and Drug Administration has not approved Awiqli. Its endocrinology and metabolic drugs advisory committee concluded in May that more information is needed about the use of the weekly insulin in Type 1 diabetes patients.
Dr. Alexander Abitbol, who is also an endocrinologist at LMC, said a key benefit of the new product is that more patients who need insulin will likely take it if it’s only once a week – helping to protect them against devastating complications if the disease is not properly treated.
“The impact for patients is that less of them will be left with high blood sugar for longer,” Abitbol said.
“High blood sugar for too long contributes to the eye disease, the kidney disease, the nerve disease, the heart disease, and all the other problems we hear about from diabetes.”
Awiqli works as a time release of insulin over the course of a week, Abitbol said.
Insulin proteins get absorbed when injected and then bind to another protein in the blood called albumin, he said. With the weekly version, they bind more tightly and then the insulin proteins gradually come off.
Abitbol, who was an investigator in the clinical trial involving Type 1 diabetes patients, said he would mostly prescribe Awiqli for Type 2 patients.
“I think that while weekly insulin is a fantastic tool for clinicians, we’re going to have to use it correctly,” he said.
“It’s not going to be for every patient with diabetes, but for those that are suitable, it will likely be a better option for them than the daily basal insulin.”
Awiqli could still be the best option for certain Type 1 diabetes patients, Abitbol said, because it’s the most practical way for them to get the treatment they need.
“The Type 1 (patient) who refuses to take their insulin and is constantly in hospital. The Type 1 who might have a developmental or cognitive disorder and whose family helps them (take insulin) but may not be able to help them every day, but might be able to help them once per week,” he said.
Dr. Ehud Ur, an endocrinologist in Vancouver who was not involved in the clinical trials, said the new weekly insulin is “another tool in the toolbox” for treating diabetes – but many patients may not be able to access it due to cost.
“It can be a good option because it gives you one needle a week rather than a needle every day,” Ur said in an interview.
“The problem is that’s offset by a huge price differential,” he said, noting that daily insulin shots – which have been around for a long time – are less expensive than a new insulin product with a patent.
Canada’s Drug Agency, which assesses drugs and recommends whether they should qualify for reimbursement under public drug plans, estimates the cost of Awiqli will be more than $1,350 a year per patient.
The agency recommends on its website that Awiqli should be funded for treatment of Type 2 diabetes, but with the condition that the price be lowered to match the least costly of the more frequent insulin injections.
It’s not yet known whether private insurers will cover the more expensive weekly injection option for patients who prefer it, but Novo Nordisk was optimistic.
“We are seeing positive early signals that private drug plans see the value Awiqli provides patients living with both Type 1 and Type 2 diabetes,” spokesperson Kate Hanna said in an email.
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