URPL alerts: Unprecedented demand for this weight loss drug causes access difficulties
Published July 11, 2023 09:17
The drug in question is liraglutide 6 mg/ml, solution for injection in a pre-filled injector. The Polish representative of the drug's manufacturer informed "that due to the fact that both in Poland and globally we are facing an unprecedented and dynamically growing demand for the drug from the GLP-1 analogue group appearing under the trade name: Saxenda (liraglutide, 6 mg/ml, solution for injection in a pre-filled injector) registered for the treatment of obesity, there may be temporary and local difficulties in access to the drug."
The Polish representative of the responsible party, Novo Nordisk, in consultation with the European Medicines Agency and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, asks for your consideration:
- Prioritize patients who are currently receiving famacotherapy with the anti-obesity drug Saxenda to increase the chance of accessing the treatment they have already started and possibly ensure continuity of care.
2. withhold initiation of new therapies with the drug Saxenda in patients who have not previously received anti-obesity therapy.
According to the Summary of Product Characteristics dated 16/12/2021, Saxenda medicinal product is indicated for use:
* in adults along with a calorie-restricted diet and increased exercise to control body weight in adult patients with an initial body mass index (BMI) of: 230 kg/sqm (obese), or 227 kg/sqm to <30 kg/sqm (overweight) with at least one co-morbid condition associated with abnormal body weight, such as disorders of carbohydrate metabolism (pre-diabetes or type 2 diabetes), hypertension, dyslipidemia or obstructive sleep apnea,
* In adolescents (2 12 years old): as an adjunct to a healthy diet and increased exercise to control body weight in adolescents 12 years old and over with: obesity (body mass index (BMI) equivalent to 230 kg/sqm in adults with the cutoff points specified in the international standard), body weight over 60 kg.
Source: URLP











