the research sprint. Time for new drugs

Like waking up after a long hibernation.

The pandemic since Covid has put the silencer on the lookout by diverting all resources towards the construction of vaccines, the choice of drugs and new treatment strategies. The rest, in the world of science and pharmaceuticals, has slowed down naturally. A sort of lethargy waiting to be able to go back to dealing with all the other pathologies and therapeutic novelties. The time seems to have arrived given the amount of new molecules just announced. For pathologies affecting millions of patients worldwide such as cholesterol high, the diabetes, depression and obesity. Medicines with particular administrations, whether they are two injections a year or a mood-balancing nasal spray, intended for niche patients who today need new pharmacological tools to have a truly tailor-made cure.

Just over a month ago, on 3 October, theItalian drug agency, approved the reimbursement of Inclisiran (it is an active principle and not the trade name) a drug produced by the biotech company Novartis for the treatment of hypercholesterolemia. New: it is administered with two subcutaneous injections a year. This is an important step forward because it works at the root of the problem, increasing the “scavengers” who clean up the blood. “This molecule – he explains Pasquale Perrone Filardi, president-elect of the Italian Society of Cardiology – is the progenitor of a new class of highly innovative drugs that directly target the root of atherosclerotic disease rather than its symptoms, thanks to a mechanism of action that allows the reduction of LDL cholesterol levels or “bad” not only effectively, but also sustained over time». Small RNA molecules are used to inhibit the formation of so-called “bad” cholesterol, directly blocking the genes that increase blood levels.

For the first time after 30 years, people with depression who do not respond to treatment, 300,000 in Italy and 100 million worldwide according to theOms, have a cure able to act faster than standard therapies. 30% of patients do not respond effectively to drugs developing a form of resistant depression. One of the main problems related to the care of depression greater, in fact, is the long interval of time that elapses before the improvement of the symptoms. An interval that can be fatal. The new drug, developed by Janssen, acts on an innovative mechanism that acts quickly and persists even after the end of the treatment. It is a molecule derived from ketamine (Esketamine), approved by the Italian Medicines Agency last April. An Italian study on the drug in nasal spray, coordinated by the D’Annunzio University of Chieti and the University of Brescia, has been published in the Journal of Affective Disorders. It is a class H drug, i.e. used only in local outpatient clinics Departments of Mental Health. To be used, therefore, under strict medical supervision and reserved only for forms of depression resistant to treatment.

A charge of new drugs is also on its way against what, Covid aside, the new epidemic is defined: obesity. The Higher Institute of Health reports that this pathology affects 11% of 18-69 year olds and 14% of over 65 year olds. to fight theobesityin recent years, in addition to lifestyle changes, specialists have relied on drugs based on agonists (they mimic the body’s regulatory molecules) of the GLP-1 receptor (a hormone produced byintestine) which are being enriched with new poly-agonists, which use two or three hormonal molecules. This class of drugs was born as a treatment for patients with diabetes but trials against obesity have also given good results. Hormones lower blood sugar after eating, as well as regulate metabolic processes related to digestion. After 72 weeks of treatment, one injection per week, with tirzepatide (non-commercial name) there was a 20.9% decrease in body weight. The medicine, produced by Eli Lilly, is not yet available in Italy.

“These pharmacological resources – he explains Paolo SbracciaProfessor of Internal Medicine at the University of Rome Tor Vergata and director of the Complex Operating Unit of Internal Medicine and the Obesity Medical Center of the Tor Vergata Polyclinic – currently represent very effective and safe pharmacotherapeutic solutions for weight loss and weight maintenance. It should be remembered that in people with diabetes they significantly reduce cardiovascular risk. What we are experiencing is a very particular moment in the history of the treatment of obesity because drugs with an excellent safety profile are finally available and able to protect against cardiovascular events, hepatic steatosis, infertility, and others”. . This is not to say that psychological therapy and, in severe cases, bariatric surgery, will be swept away.