Ema approves weekly insulin. Diabetes Association: 'momentous news'

The European Commission has granted authorisation for Novo Nordisk's weekly insulin Awiqli, the world's first indicated for the treatment of diabetes in adults. "The drug," a note explains, "is designed to cover basal insulin requirements for an entire week with a single subcutaneous injection and has been approved for adults with diabetes mellitus.

Novo Nordisk has also received regulatory approvals for Awiqli in Switzerland and Canada for the treatment of both type 1 and type 2 diabetes in adults. Today, insulin therapy requires the patient to administer insulin at least once a day 'with an impact ranging from the management of the therapy itself to the social, work and psychological sphere of the person and their families'. In phase 3 clinical trials, weekly insulin 'allowed a reduction in blood glucose (measured as a change in HbA1c) compared to daily basal insulin by promoting glycaemic control in people with type 2 diabetes'.

A 'revolution' that comes a century, or 100 years, after the invention of insulin itself, experts say. The icodec molecule, manufactured by Novo Nordisk, is the world's first slow-release and has received approval from the European regulatory body to be marketed in Europe on the basis of safety and efficacy data from the phase 3a Onwards study. An innovation described as 'revolutionary' by both patients and physicians.

According to the president of the Italian Society of Diabetology (Sid), Angelo Avogaro, this is a 'long-awaited innovation with positive effects both clinically and socially', and the hope is that now the Italian Medicines Agency (AIFA) will 'give its approval for this innovative insulin as soon as possible'. The improvement is evident in disease management, explains Avogaro, because the new insulin has been shown to improve glycaemic control, compared to the daily version, without an increased risk of hypoglycaemia. What's more, fewer injections offer more flexibility for daily routines, travel and social activities. And reducing frequent injections can decrease the stress, anxiety and depression associated with diabetes. The benefits are also for the environment, thanks to the reduction in the number of pens used and hence the use of plastic. The simplification of the treatment also promises to improve therapeutic adherence, ultimately enabling better glycaemic control, points out the president of the Associazione Medici Diabetologi (Amd) Riccardo Candido, who speaks of the "first major pharmacological innovation in more than a century".

Patients' associations also applaud. "Being able to switch from at least one daily injection to a weekly one gives diabetics the freedom of not having to plan every single day according to their therapy, but having the peace of mind of knowing that a single weekly injection can guarantee the same effectiveness and safety. It also means helping patients overcome social, work and psychological difficulties,' says Stefano Nervo, president of Diabetes Italia. Emilio Augusto Benini, president of Fand Associazione Italiana Diabetici, calls it 'epoch-making news for the concrete improvement it offers to the quality of life'. Now, he says, 'we appeal to Aifa, so that it does not dampen our enthusiasm with long waits'. A positive verdict also comes from the presidents of the parliamentary intergroup on obesity, diabetes and chronic non-communicable diseases, who met with the company Novo Nordisk today. For sure, the weekly insulin will have an impact on millions of people in our country: Italians suffering from diabetes are about 6% of the population, i.e. almost 4 million, but the figure is underestimated if we consider that there are about 1.5 million missed diagnoses.