New Delhi: Danish pharmaceutical giant Novo Nordisk is set to apply for the regulatory approval of its once-a-week insulin drug, Icodec, in the US, European Union and China, according to the company’s financial report for the first quarter of the current financial year, which was released last week.
It is likely that the approval may come as soon as the second quarter of this financial year, followed by its availability for commercial use as the world’s first once-a-week insulin drug, sources told ThePrint.
Researchers and clinicians alike see Icodec as a potential game-changer for millions of diabetics around the world who require insulin therapy. Current treatment requires daily insulin injections, or for some patients multiple injections per day.
The arrival of the drug is highly anticipated in India, which is often referred to as the “diabetes capital of the world”. There are an estimated 77 million people above the age of 18 suffering from Type 2 diabetes in India, besides another 25 million who are prediabetics, according to World Health Organisation (WHO) data.
Type 1 diabetes is usually genetic and appears early in life, while Type 2 is associated with lifestyle and occurs over the years.
The final results of the 52-week phase-3 clinical trials for Icodec, conducted across 80 sites in nine countries including India, to test its safety and efficacy, were published in The Lancet journal last week.
According to the Lancet article, findings showed that in people with long-standing Type 2 diabetes on a basal-bolus regimen (multiple injections a day), a once-a-week dose showed similar improvements in glycaemic control, compared to once-a-day insulin. In addition, findings also showed that there were no significant safety concerns with the drug.
“Currently, the longest working insulin only covers 24 hours and many patients are reluctant to take it daily,” Dr Anoop Misra, chairman of the Fortis C-DOC Hospital for Diabetes and Allied Sciences, told ThePrint.
“Once a week insulin will be a great advancement,” he added.
However, a spokesperson with Novo Nordisk in India, when contacted, said there is no update on when the drug may be launched in India.
“We will be holding around 1.5 months on hand (MOH) stocks with Novo Nordisk India Private Limited, and around 2.5 MOH with our distributor Abbott [once the drug is launched in India],” the spokesperson said in response to queries by ThePrint.
The spokesperson added: “In total, around 4 MOH stocks at country level will be maintained.”
Senior executives in the company, in a press conference in February this year, had announced that Icodec may be available in India by 2025.
No escaping the prick, but easy regimen
According to Dr V. Mohan, chairman and chief diabetologist of Chennai-based Dr. Mohan’s Diabetes Specialities Centre, insulin is a hormone and ever since its discovery in 1921, it has saved the lives of millions of people with diabetes.
“However, the one thing which people dread is having to inject themselves every day and insulin, being a protein, gets destroyed if taken as a tablet by the hydrochloric acid in the stomach,” he explained.
Hence, to bypass it and to get it directly into the blood, injecting insulin has been the preferred method all these years, he added.
“Obviously, for people who have to take insulin every day, if it can be replaced with a less frequently needed insulin, it would be a big boon. This is where the once weekly insulin will play a big role,” he told ThePrint.
Pharma companies have been working on a slow-release (long-acting) insulin which can be injected once a week.
According to Mohan, drugs like Icodec, however, may be more beneficial for those with Type 2 diabetes — in diabetics who need just one injection a day of a long-acting insulin on a basal-bolus regimen
“For children and adults with Type 1 insulin-dependent form of diabetes, they require up to four injections a day or more — one with short-acting (insulin) with every meal and the other, a long-acting insulin, given once a day,” he said.
In such people with Type 1 diabetes, the once-a-week insulin will not be able to replace the short-acting insulin given with every meal, but may be able to replace the long-acting insulin, he said.
(Edited by Amrtansh Arora)
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