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European Regulatory Body Seeks Stakeholder Input on Future PGx Guidance

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Originally published Jan. 30.

The European Medicines Agency is seeking stakeholder input on how best to use pharmacogenomics data to advance personalized medicines.

The EMA's Committee for Medicinal Products for Human Use last week released a consultation document stating the need for guidelines that outline best practices for using pharmacogenomics strategies in early drug development, in the post-market setting, and to inform medical product labeling.

With input from stakeholders, CHMP is planning to issue a draft guidance "for both industry and regulatory authorities regarding the application of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products." The advice in this document should also "support the development of methodologies for monitoring of the effectiveness of genetic biomarker use in the clinical setting," CHMP said.

The guidance document will be developed by the Pharmacogenomics Working Party and Pharmavigilance Working Party. Stakeholders have until March 15 to submit comments to CHMP regarding the development of the guidance document.

CHMP anticipates issuing a draft guidance in nine to 12 months. At that point, stakeholders will have three months to provide comments on the draft document before final guidelines are issued.

As CHMP develops this guidance, the committee is specifically seeking input from stakeholders on how PGx strategies can be used to craft a risk-management plan for a subpopulation of patients suspected to experience limited benefits or adverse reactions to a drug; when patients with certain genomic markers may need to be monitored in the post-marketing setting to ensure they are receiving the appropriate dose of a drug or the right co-medications; as well as how and when to collect biological samples during clinical trials to facilitate retrospective molecular analysis.

Stakeholders are also to comment on methodologies for conducting PGx studies regarding lack of efficacy or safety in the post-marketing setting; on the level of evidence needed to confirm a PGx signal with regulatory authorities; and on risk minimization measures depending on the clinical impact of a PGx interaction.

Additionally, CHMP is also seeking input on several labeling issues raised by greater incorporation of PGx data into drug development. For example, what pharmacogenomic information should be included in the product information and how does PGx information in labeling impact the use of the medical product?

CHMP is hoping that by providing greater clarity on the application of pharmacogenomics measures, such a guidance will spur "the uptake of personalized medicines in clinical use."

"In spite of advances in the understanding of inter-individual differences and their genetic basis, the occurrence of rare but serious adverse drug reactions or lack of efficacy/effectiveness are often identified at a late stage of drug development or long after drug approval," CHMP states in the consultation document.

"Knowledge and awareness of the presence or absence of a genetic variant may in many cases permit estimation of the likelihood of occurrence of ADRs or of effectiveness with the use of genetic information or tests. Currently, there is limited information on the utilization of a genomic biomarker during follow up (post marketing) or on the effect of labeling with genomic information," CHMP adds.

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