Many Canadian people with diabetes will now be able to take their insulin once a week instead of daily, drug maker Novo Nordisk announced Monday.
The insulin, Icodek, sold under the brand name Awikili, is the world’s first once-weekly basal insulin injection and is set to be available nationwide from June 30, the company told The Canadian Press ahead of the announcement.
The product was approved by Health Canada in March for the treatment of adults with type 1 and type 2 diabetes, making Canada the first country to receive it.
“I think this is a huge deal,” said Dr. Harpreet Bajaj, chair of the Canadian Diabetes Association’s clinical practice guidelines steering committee.
“It’s going to really help ease the burden on people who need insulin injections,” said Bajaj, an endocrinologist at LMC, a publicly funded diabetes and endocrinology clinic based in southern Ontario and Calgary.
He said some of his patients had been taking part in clinical trials for Awickri and had been asking when it would be available to them because they had had to go back to daily injections since the study ended.
Weekly insulin is approved by Health Canada to treat both types 1 and 2 diabetes, but endocrinologists say it’s mostly effective for people with type 2 diabetes.
The main reason, Bajaj said, is that people with type 1 diabetes cannot produce insulin themselves, so they must take additional fast-acting insulin injections every day with each meal.
People with type 2 diabetes make insulin but not enough or their bodies can’t use it properly. Basal insulin injections get insulin levels to the right level during fasting, while other drugs can suppress “sugar spikes that come with meals,” Bajaj said.
A series of randomized clinical trials of Awickri in many countries, including Canada and the United States, were conducted primarily in people with type 2 diabetes. Only one study has been conducted in people with type 1 diabetes, which found that these patients were at higher risk of hypoglycemia when taking once-weekly insulin options.
The U.S. Food and Drug Administration has not approved Awickri. The agency’s Endocrine and Metabolic Drugs Advisory Committee concluded in May that more information is needed about once-weekly insulin use in people with type 1 diabetes.
Dr. Alexander Abitbol, also an endocrinologist at LMC, said the main benefit of the new product is that many patients who need insulin are likely to use it if only once a week, helping to protect them from dire complications if their disease is not properly treated.
“The impact on patients is that fewer patients will experience long periods of hyperglycemia,” Abitbol said.
“High blood sugar over a long period of time can lead to eye disease, kidney disease, nerve disease, heart disease and all the other problems we commonly hear about with diabetes.”
Awickri works by slowly releasing insulin over a period of one week, Abitbol said.
When the insulin protein is injected, it is absorbed and binds to another protein in the blood called albumin, he said. In the once-weekly version, the bond becomes tighter and the insulin protein gradually falls off.
Abitbol, who was a researcher in clinical trials involving people with type 1 diabetes, said he would prescribe Awickri primarily to people with type 2 diabetes.
“Weekly insulin dosing is a great tool for clinicians, but I think it needs to be used correctly,” he said.
“It won’t work for everyone with diabetes, but for those who are suitable, it could be a better option than daily basal insulin.”
Abitbol said Awickri may still be the best option for certain people with type 1 diabetes because it’s the most practical way for them to get the treatment they need.
“Type 1 diabetes patients who refuse to take their insulin and are hospitalized all the time. Type 1 diabetes patients who may have developmental disabilities or cognitive disabilities and whose family members are helping them take their insulin, but they may not be able to help every day, but they may be able to help once a week,” he said.
Dr. Ehud Ull, a Vancouver endocrinologist who was not involved in the trial, said the new once-weekly insulin is a “new tool” in diabetes treatment, but that cost may make it inaccessible to many patients.
“One injection a week would be a better option than daily injections,” Ull said in an interview.
“The problem is that it’s offset by a big price difference,” he said, noting that daily insulin injections, which have been around for a long time, are cheaper than the newer patented insulin products.
The Canadian Drug Agency, which evaluates drugs and recommends whether they should be reimbursed by public drug plans, estimates that Awickri will cost more than $1,350 per patient per year.
The agency recommends on its website that Awickri should be funded to treat his type 2 diabetes, provided that the price is reduced to match the cheapest of the more frequent insulin injections.
It remains to be seen whether private insurers will cover the more expensive once-weekly injection option for patients who want it, but Novo Nordisk was optimistic.
“There are early positive signs that private drug plans are recognising the value Awickri can bring to people with type 1 and type 2 diabetes,” spokeswoman Kate Hanna said in an email.
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