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FDA, EMA Seek Input on Companion Diagnostics, Genomic Biomarkers

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Regulators in the U.S. and Europe have each posted requests for public comment on issues affecting the development of medicines by drug companies.

The U.S. Food and Drug Administration (FDA) recently issued a new draft guidance to facilitate the development and review of companion diagnostics. The proposed policy states that personalized treatments (targeted drugs or therapies) would gain approval only after their accompanying diagnostic devices also receive approval. There is an exception for treatments of serious or life-threatening conditions.

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said:

These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability. It is the agency’s goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients.

The draft is open for comments until September 10th, 2011.

The European Medicines Agency (EMA) recently released a reflection paper on methodological issues associated with the use of ‘genomic biomarkers’ for clinical development and patient selection.

The paper focuses predictive biomarkers and prognostic biomarkers. Predictive biomarkers offer clues about response (safety, efficacy or metabolic) to a particular therapeutic intervention while prognostic biomarkers indicate disease prognosis and may not relate to specific intervention.

The paper discusses the role that DNA markers play in predicting which patients are likely to benefit from medicines or may be susceptible to side-effects. It also deals with the co-development of a genomic biomarker diagnostic test for use with a medicinal product.

Genomic biomarkers may provide a range of applications in clinical drug development, including patient selection, stratification of treatment strategies or patient groups, early evaluation of treatment effect including adverse reactions, and prognosis. They may also be used for pre-defined subgroup analysis or to enable novel trial designs that might not be possible otherwise due to heterogeneity of clinical characteristics.

The paper is open for comments until 25 November 2011.

Source: U.S. Food and Drug Administration

Source: European Medicines Agency