The authorization covers a tablet form of semaglutide, a drug that mimics the action of glucagon-like peptide 1 (GLP-1), a hormone naturally produced mainly in the intestine after eating.
The decision marks another step in the rapid development of drug treatment for obesity, which doctors increasingly treat as a chronic, relapsing disease rather than a problem addressed solely through diet and exercise.
For patients in Poland, however, European Union authorization does not mean the tablets will immediately appear in pharmacies or be reimbursed by the public health system.
Karolina Kędzierska-Kapuza, a diabetologist and nephrologist who also treats obesity, said the manufacturer must decide when to introduce the medicine to the Polish market, secure supplies and complete national procedures.
Reimbursement is a separate process involving clinical and economic assessment and negotiations with Poland’s health ministry.
Kędzierska-Kapuza said it was therefore too early to give a firm date for either availability or reimbursement.
Semaglutide is already used in Poland in the treatment of type 2 diabetes, including in oral form. Some patients with diabetes can receive subsidized treatment, but only if they meet detailed clinical criteria.
Drug treatment for obesity is not currently generally reimbursed in Poland, while bariatric surgery can be publicly funded for patients who qualify.
The new approval gives patients another way of taking a medicine that has become central to modern obesity treatment.
Injectable semaglutide is usually administered once a week, while the oral version is taken daily and must be used according to specific instructions concerning meals, drinks and other medicines.
“The most important advantage is choice,” Kędzierska-Kapuza said.
Some patients fear injections or simply prefer tablets, while others may find a weekly injection easier than remembering a daily dose.
Semaglutide belongs to a class of medicines called GLP-1 receptor agonists. Natural GLP-1 helps regulate blood sugar, appetite and the feeling of fullness after eating.
In the pancreas, it stimulates beta cells to release insulin when blood glucose is elevated. It also reduces the release of glucagon, a hormone that raises blood sugar. In addition, GLP-1 slows the emptying of the stomach and acts on areas of the brain involved in appetite regulation, helping people feel full for longer and reducing hunger.
Natural GLP-1 breaks down within minutes, making it unsuitable as a medicine in its original form. Researchers therefore developed molecules that activate the same receptor but remain active in the body for much longer.
These drugs were initially developed mainly for people with type 2 diabetes. Their effect on appetite and body weight led to studies of their use in people with obesity.
Other medicines in this field include liraglutide and tirzepatide. Tirzepatide acts on both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptors, so it differs from drugs that target the GLP-1 receptor alone.
Drug treatment for obesity can generally be considered for adults with a body mass index (BMI) of at least 30.
It may also be appropriate from a BMI of 27 when a patient has a weight-related condition such as type 2 diabetes, high blood pressure, abnormal blood fats, cardiovascular disease or obstructive sleep apnea. Exact eligibility depends on the medicine and the patient’s health.
Kędzierska-Kapuza stressed that medication is part of broader treatment. A balanced diet and regular physical activity remain important, particularly resistance exercise, which helps preserve muscle mass during weight loss.
Because obesity is chronic and often recurrent, treatment may also need to continue after the desired weight reduction has been achieved. Patients should not stop treatment or change between oral and injectable forms without consulting a doctor, she said.
The most common side effects of GLP-1 drugs affect the digestive system and include nausea, vomiting, diarrhea, constipation, abdominal pain, heartburn and a feeling of excessive fullness.
They are often strongest when treatment begins or after a dose increase, which is why doses are usually raised gradually.
The medicines may also increase the risk of gallbladder problems, particularly during rapid weight loss. Acute pancreatitis is rare, but severe and persistent abdominal pain, especially if it radiates to the back, requires urgent medical attention.
Kędzierska-Kapuza also warned against using medication prescribed to someone else or buying semaglutide from uncertain sources.
The benefits of GLP-1 drugs can extend beyond weight loss and glucose control. Clinical studies have shown that selected medicines in the class can reduce the risk of serious cardiovascular events, including heart attack and stroke, in appropriately selected patients.
Research has also found benefits for some patients with type 2 diabetes and chronic kidney disease.
Kędzierska-Kapuza cautioned that semaglutide does not repair kidneys that are already damaged, but it may slow disease progression and reduce the risk of complications.
For Polish patients waiting for wider access to obesity medication, the EU decision opens another treatment option. Whether it becomes readily available, and affordable, will now depend on decisions taken in Poland.
(rt/gs)
Source: zdrowie.pap.pl