2023-11-11 18:47:27
It was early March when the Italian drug agency Aifa published an important information note: “The increase in demand for Ozempic* (semaglutide) has led to shortages that are expected to continue throughout 2023”, wrote the national regulatory body, specifying that the drug “is indicated exclusively for the treatment of adults with inadequately controlled type 2 diabetes mellitus in addition to diet and exercise. Any other use, including weight management, represents an off-label use and currently puts availability at risk for the indicated population.”
The alert arrived at the height of the ‘popularity’ of semaglutide, driven skyrocketing by scientific data, but also by showers of videos from influencers on TikTok and involuntary ‘testimonials’, such as the entrepreneur and owner of Tesla and Space Musk, who said he used the version designed for weight loss (Wegovy*). A wave that also hit the manufacturing company, the Danish Novo Nordisk, which in September managed to overtake leading groups in the luxury sector such as LVMH in terms of capitalization on the stock market, with values that had already, albeit slightly, exceeded the Danish GDP itself ( which in turn took off with upward forecasts for the future).
“Today in Italy there are 5 molecules” of this family “that the diabetic patient has at his disposal”, Angelo Avogaro, president of the Federation of scientific diabetology societies SID and AMD, explains to time.news Salute. “These are semaglutide, exenatide, liraglutide, dulaglutide and lixisenatide”, Glp-1 receptor agonist drugs. “They are ‘game changers’ – the specialist defines them – because they have been shown to reduce not only blood sugar levels but, unlike drugs in the past, to also correct other risk factors, especially weight. And above all they protect the system cardiovascular disease from stroke and heart attack. So they are very important” due to the more impactful action they have on sweet blood disease. A disease that is now defined as a ‘silent pandemic’, the contours of which are remembered by specialists as World Diabetes Day approaches (14 November). “In Italy alone there are around 4 million people with type 2 diabetes and to these must be added a million people who have it and don’t know they have it”, recalls Avogaro.
Given the numbers of patients present in the world, the demand for these new drugs is high almost everywhere. Even at a European level, where shortage problems have also been reported. The situation today is not yet completely stabilised, Marco Cavaleri of the European Medicines Agency EMA reports to time.news Salute, recalling that there are “two products specifically approved for weight control” in the EU area, “while the others are for the treatment of type 2 diabetes”. Including tirzepatide, the latest promising arrival, which in the USA has recently received the FDA green light also for obesity.
Tirzepatide “has the added fact that two different proteins have been placed in a single molecule – explains Avogaro – which act on two different receptors and for reasons that are not yet very clear there is an enhancement of Glp-1, so at the maximum dose of 15 mg can reduce weight up to 21 kg. For the very obese and for those who have a body mass index above 35, people who are used to following an unsuccessful diet 365 days a year, they are important tools.”
In short, there is excitement in the world of the fight against diabetes about these new weapons. But with popularity also comes ‘fakes’. And the EU regulatory body, recalls Cavaleri, “has issued an alert regarding some counterfeit versions” of Ozempic intercepted in some countries. The counterfeit pre-filled pens were very similar to the original and had unique batch numbers, 2D barcodes and serial numbers from original packaging, which were found to be inactive. The investigations are ongoing. “It is a phenomenon that obviously worries us specialists – observes Avogaro – We are in fact involved in falsification, which is a serious risk for the patient”. Returning to the issue of deficiencies, today in Italy “we detect them in certain areas and not in others – reports the expert – The real problem is that Glp-1 agonists are also used by many in an inappropriate manner for the treatment of overweight and then” the effect is that “they are lacking for patients with diabetes. I say: you shouldn’t waste it”. Use without medical supervision “is a problem that concerns more the USA – he points out – because in Italy everything is very closely traced. These drugs must be prescribed with Aifa’s Note 100, which says exactly what the prescription terms are”.
What’s in the future of treatments for diabetes patients? “Today we have these drugs approved and reimbursed by the National Health Service for diabetes. It should be noted in this regard that there is no drug that is effective in the long run if an adequate lifestyle is not also implemented. An aspect that should not be forget”, Avogaro remarks. As for future scenarios, in the future there are “the promises of a technology that is advancing rapidly, at record paces”, he assures. “The whole part of the glucose determination is thus improving, which is even done with sensors under the skin that are kept for months. And we understand the great advantage for a diabetic accustomed to puncturing himself 7 times a day”. But “we also see the current technology in transplantation and in new studies with stem cells”.
World Diabetes Day will be an opportunity to take stock. This year’s slogan? “Diabetes is a very common disease”, recalls Avogaro, explaining the meaning of the message. “It is common because it is a disease that has a prevalence of around 6%, which tends to be much higher than the national average in the southern regions. It is common because in addition there are also a million Italians who have diabetes, but they don’t know they have it. And it is common in the sense that the citizen with diabetes is a citizen like the others, who must not be subject to discrimination of any kind. We must eliminate any stigma about the disease. We have also signed a protocol with the Anci and the Italian Municipalities precisely to underline the fact that the disease is very frequent in the population”.
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