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Liraglutide

Summary

The active substance liraglutide is a peptide and is not considered to have any environmental impact. However, Fass writes the following: Even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as biologically active.

This summary information comes from assessement reports and Fass.se.

Detailed information

Assessment report

There are several assessment reports with the same information. Presented here what is in the assessment report for Saxenda (liraglutide), Novo Nordisk, 25 March 2021, EMA / 217044/2021 for a type II variation.

"An ERA has been submitted. The ERA consists of a justification for not performing any ERA studies. Liraglutide is a peptide consisting of natural amino acids and a natural fatty acid (palmitic acid). Therefore, in accordance with the guidance (EMEA/CHMP/SWP/4447/00 corr 21*), liraglutide is exempted from performing ERA studies, under the expectation that e.g. due to their nature they are unlikely to result in a significant risk to the environment. Any increase in consumption of liraglutide, is considered not to have any impact on the environment. [...] Considering that liraglutide is a peptide with a fatty acid, is not expected to pose a risk to the environment."

Fass environmental information

Fass environmental information for Saxenda (liraglutide) (downloaded 2022-03-21).

Risk

The use of amino acids, proteins and peptides is not considered to have any environmental impact.

Detailed information

According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00) vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.

Although biomolecules such as vaccines and hormones are excluded, they should still be considered biologically active.

Author: Health and Medical Care Administration, Region Stockholm