Pharma regulators consult on drug development initiatives
pharmafile | July 13, 2011 | News story | Research and Development | Companion Diagnostics, EMA, FDA, Pharmacogenomics, biomarkers, research and development news
Pharma regulators in the US and Europe have put out separate consultations on issues affecting how medicines are developed.
The FDA is seeking comment on its proposed policy for diagnostic tests, while the European Medicines Agency wants views on genomic markers in medicine development.
The FDA has issued draft guidance for companies on the US regulator’s policy for reviewing a companion diagnostic and the medicine which goes with it.
Billed as part of the FDA’s efforts to promote personalised medicines and diagnostics, interested parties have two months to submit their views on the document.
“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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
“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,” he added.
The guidance also recommends early engagement between the FDA and manufacturers to ensure the “agency’s expectations are included in development plans”.
The FDA cites the success of Herceptin, approved with a companion test, in treating breast cancer by targeting HER2 gene amplification or HER2 protein over-expression.
The draft guidance gives notice of the FDA’s intention to conduct simultaneous reviews of therapies and their corresponding companion diagnostics.
It also highlights when it might approve a targeted medicine in the absence of a cleared diagnostic – for example where the therapy is for a serious or life-threatening disease for which no treatment exists, and the potential benefits outweigh the risks.
Meanwhile the EMA consultation is accompanied by what the European regulator calls a ‘reflection paper’ on genomic markers.
This discusses the role that markers in the DNA can play in predicting which patients are likely to benefit from medicines or will experience side effects.
Prepared by the Committee for Medicinal Products for Human Use’s pharmacogenomics working party, the paper also looks at markers’ role in understanding how medicines work and selecting patients for inclusion in clinical trials and evaluating treatments.
The EMA’s reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection is open for comments until 25 November.
Adam Hill
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