The Spanish Agency for Medicines and Health Products (Aemps) recently authorized the use of the drug Wegovy, indicated to control type 2 diabetes, for weight control and with the aim of alleviating the supply problems faced by GLP-analogue medicines. 1.
This was announced on April 24 by the agency, a body attached to the Ministry of Health, in a statement in which it said it expected this drug to be marketed in Spain starting this May and in which it updated the situation of the supply problems. of GLP-1 analogue medications and some of the recommendations for health professionals.
In 2022, the Aemps already issued a series of measures to “avoid or alleviate” supply problems with these medications, “especially” for Trulicity and Ozempic, in their different presentations and, subsequently, updated them on September 8, 2023. The difference between Ozempic and Wegovy is in the dosage, which is a maximum of 1 milligram weekly for diabetes and can reach 2.4 milligrams for obesity.
GLP-1 analogue medications are authorized to improve glycemic control in the treatment of adults with type 2 diabetes mellitus (DM2) not sufficiently controlled with diet and exercise, according to the Aemps.
These drugs are indicated in monotherapy, when metformin is not considered appropriate due to intolerance or contraindication, or in association with other medications used in the treatment of diabetes and, in addition, some GLP-1 analogues are also authorized for weight control. “in certain situations,” this agency warned.
Until now, only Saxenda was authorized for the indication of weight control, but recently several presentations of Wegovy have been authorized and, according to Health, "in both cases, the indication for weight control is always in combination with nutrition healthy and an increase in physical activity.”
In the case of Wegovy, it is only administered as a subcutaneous injection once a week and the European Medicines Agency has already approved it for three groups: adults with a body mass index (BMI) greater than 30 (the limit from which a person is considered obese); adults with a BMI between 27 and 30 (considered overweight but not obese) if they have at least one serious health problem associated with excess weight; and adolescents over 12 years of age with obesity and weighing more than 60 kilos.
Furthermore, two medications from the same therapeutic group that were indicated as alternatives, Byetta and Lyxumia, have ceased marketing and, despite these measures to “alleviate the impact of the high demand” for these products for the treatment of diabetes, patients “They continue to be affected by the supply problems that began at the end of 2022,” according to Aemps.
For this reason, he recalled the need to “adjust” prescriptions to “prioritize” the use of these treatments for glycemic control in patients with DM2, understanding that therapeutic alternatives for these patients “may be more complex.”
"On the other hand, the inspection services of the autonomous communities have detected cases of prescription of these medications for indications not included in their technical sheet or without complying with the indications given by the competent authorities and cases have been detected in which they are dispensed without the corresponding medical prescription,” denounced the Aemps, convinced that this “may give rise to the administrative responsibilities provided for in the legislation.”
In this context, he pointed out that the incumbent laboratories “continue working” on measures to “increase their manufacturing globally and meet needs,” although he noted that, while this is being carried out, “supply tensions may continue to occur.” .
To “facilitate” the monitoring of this type of problem, the Aemps has a list of active supply problems whose information is kept “permanently updated.”
