Category 3 unresponsive to unresponsive to IST IST ELT116643 Safety in Safety in May 2016 SAA patients SAA Clinical receiving patients Category 3 treatment with receiving IST treatment with Ongoing IST RAD201583 Drug-drug Determine September interaction (DDI) effect of 2015 Clinical and cyclosporin on –cyclosporin Category 3 eltrombopag PK of eltrombopag Planned RAD200936 Paediatrics Safety of December eltrombopag in 2020 Clinical paediatric SAA Category 3 Planned Risk minimisation activities The sponsor is proposing routine risk minimisation activities. In the EU-RMP, the sponsor is proposing health care professional and patient education as additional risk minimisation activities. However, in the ASA, the sponsor states the following: No additional risk minimisation measures are planned following the extension of indication to SAA patients. The risk communication in the product labelling associated with cytogenetic abnormalities is considered to be the primary risk minimisation tool and is sufficient to inform prescriber and patient. Reconciliation of issues outlined in the RMP report Table 7 summarises the first round evaluation of the RMP, the sponsor’s responses to issues raised by the evaluator and an evaluation of the sponsor’s responses. Table 7: Reconciliation of issues outlined in the RMP Evaluation Report (Round 1) Recommendation in RMP Sponsor’s response (or RMP evaluator’s evaluation report summary of the response) comment 1. Safety considerations may Pharmacodynamic, The sponsor’s be raised by the nonclinical pharmacokinetic, and response has been and clinical evaluators toxicological evaluations with noted. through the consolidated eltrombopag were completed request for further as part of the nonclinical information and/or the program in support of the Clinical Evaluation Report. It is initial registration for important to ensure that the Revolade and the subsequent information provided in application to register the response to includes a HCV Indication. There are no consideration of the relevance new nonclinical
Category 3 unresponsive to IST unresponsive to IST ELT116643 Clinical Category 3 Ongoing Safety in SAA patients receiving treatment with IST Safety in SAA patients receiving treatment with IST May 2016 RAD201583 Clinical Category 3 Planned Drug-drug interaction (DDI) –cyclosporin and eltrombopag Determine effect of cyclosporin on PK of eltrombopag September 2015 RAD200936 Clinical Category 3 Planned Paediatrics Safety of eltrombopag in paediatric SAA December 2020 Risk minimisation activities The sponsor is proposing routine risk minimisation activities. In the EU-RMP, the sponsor is proposing health care professional and patient education as additional risk minimisation activities. However, in the ASA, the sponsor states the following: No additional risk minimisation measures are planned following the extension of indication to SAA patients. The risk communication in the product labelling associated with cytogenetic abnormalities is considered to be the primary risk minimisation tool and is sufficient to inform prescriber and patient. Reconciliation of issues outlined in the RMP report Table 7 summarises the first round evaluation of the RMP, the sponsor’s responses to issues raised by the evaluator and an evaluation of the sponsor’s responses. Table 7: Reconciliation of issues outlined in the RMP Evaluation Report (Round 1) Recommendation in RMP evaluation report Sponsor’s response (or summary of the response) RMP evaluator’s comment 1. Safety considerations may be raised by the nonclinical and clinical evaluators through the consolidated request for further information and/or the Clinical Evaluation Report. It is important to ensure that the information provided in response to includes a consideration of the relevance Pharmacodynamic, pharmacokinetic, and toxicological evaluations with eltrombopag were completed as part of the nonclinical program in support of the initial registration for Revolade and the subsequent application to register the HCV Indication. There are no new nonclinical The sponsor’s response has been noted.
auspar-eltrombopag-160330.docx