Abiraterone

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Assessment report for Zytiga

Assessment report for Zytiga (abiraterone) 12 October 2017, EMA/816845/2017.

Hazard

Persistence: "DT_{50, freshwater} = 2.3 days, DT_{50, sediment} = ND, DT_{50, whole system} = 4.9 and 3.3 days % shifting to sediment = sediment-bound residue 28.2% and 22.1%."

Bioaccumulation: log K_ow = 5,12. BCF = "903 (for low conc, 0.13 μg/L), 931 (for high conc, 1.3 μg/L)." Conclusion: B.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (fathead minnow partial life cycle) 0.013 microg/L. Conclusion: T.

PBT-statement: "The compound is considered as T."

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC_surfacewater = 0.004 microg/L

PNEC = Lowest NOEC 0.013 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.0013 microg/L

PEC/PNEC = 3.077

Assessment report for Abiraterone Krka, Abiraterone Mylan and Abiraterone Accord respectively

Assessment report for Abiraterone Krka 22 April 2021, EMA/653711/2021. Corresponding information can be found in the two other assessment reports.

"No Environmental Risk Assessment studies were submitted. This was justified by the applicant as the introduction of Abiraterone KRKA is considered unlikely to result in any significant increase in the combined sales volumes for all abiraterone acetate containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar. SmPC of the generic product, section 5.3 contains the same information as the innovator: “The active substance, abiraterone, shows an environmental risk for the aquatic environment, especially to fish.”

Fass environmental information

Fass environmental information for Zytiga (abirateron) (downloaded 2024-06-14).

Hazard

Persistence: "Taunton River Aerobic DT₅₀ (Days) Total system = 4.9, Weweantic River Aerobic DT₅₀ (Days) Total system = 3.3. Abiraterone acetate is degraded in the environment."

Bioaccumulation: Log D_ow > 6.20 (pH = 6.10), "BCFlow dose = 903, BCFhigh dose = 931. Abiraterone acetate has high potential for bioaccumulation."

Kronisk toxicitet: There is NOEC for 3 trophic levels, lowest NOEC for fish (fathead minnow Pimephales promelas 119 days) = 0.013 microg/L.

Conclusion for PBT-assessment

"According to the established EU-criteria Abiraterone acetate should not be regarded as a PBT substance."

Risk

PEC/PNEC is based on sales data in Sweden in year 2020. PEC/PNEC = 40,0862 which gives the risk high.