Evolocumab

Detailed information

Assessment report

Assessment report for Repatha (evolocumab) 21 May 2015, EMA/CHMP/222019/2015.

"No ERA have been done, which is agreed seen the nature of the product. Evolocumab is a protein composed of normal amino acids and readily biodegradable. Therefore it does not pose a risk for the environment."

Assessment report

Assessment report for Repatha, 22 February 2018, EMA/233126/2018.

"No environmental risk studies were included in this application. The applicant submitted a justification stating that evolocumab is considered to be a non-hazardous, biodegradable product. The environmental risk in terms of use and disposal was considered to be negligible and, therefore, did not require further testing as per the EU Enviromental Risk Assessment Guideline. Furthermore, the assessment performed does not indicate a requirement to take special precautions during the release to the environment that will result from use in patients or disposal of the product. As such, it is not considered necessary to include warnings or precautions within the product information in relation to environmental risks. The CHMP agreed with the conclusions of the Applicant."

Fass environmental information

Fass environmental information for Repatha from Amgen (downloaded 2023-09-25).

Risk

The use of amino acids, proteins and peptides is not expected 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.