Lurasidone

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 are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

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, as well as possibly other products from the same company, not all medicinal products containing the same active substance.

Assessment report Latuda 2014

Assessment report for Latuda (lurasidone), 23 January 2014, EMA/113836/2014.

Hazard

Persistence: "DT₅₀ or ready biodegradability = 191 days."

Bioaccumulation: BCF = 2 798–2 585.

Chronic toxicity: There is NOEC for three trophic levels, lowest NOEC for crustacean (Daphnia magna) 26 microg/L.

Risk

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

PEC = 0.8 microg/L

PNEC = Lowest NOEC 26 microg/L/10 (Assessment Factor (AF) for three chronic studies) = 2.6 microg/L

PEC/PNEC = 0.308 which gives the risk low.

"In conclusion, lurasidone is not a PBT substance and is not expected to pose a risk to the environment."

According to the environmental risk assessment, lurasidone was initially proposed as a PBT substance due to its high bioaccumulation potential (BCF > 2000). However, it does not meet the T-criterion based on ecotoxicity data, and although some reproductive toxicity was observed, the overall evidence was not considered sufficient for PBT classification. Therefore, lurasidone is not regarded as an environmental concern and no special warnings are required in the product information.

Assessment report Latuda 2020

Assessment report for Latuda type II variation indication for the treatment of schizophrenia in adolescent from 13 years and over 23 July 2020, EMA/59804/2021.

An environmental risk assessment (ERA) was submitted in the initial application for Latuda. In this variation, no updates to the ERA have been provided, but the applicant submitted a justification. The assessment concluded that the use of lurasidone hydrochloride at the maximum recommended daily dose (160 mg/day) poses no relevant environmental concern. Since the dose for adolescents (80 mg/day) is lower and the default market penetration factor (Fpen = 0.01) is conservative, the previous ERA is considered applicable to this indication. Therefore, no further updates are required.