Regulatory Focus™ > News Articles > European Regulators Want New Gout Guidelines

European Regulators Want New Gout Guidelines

Posted 14 June 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) on Thursday released a new concept paper calling for new guideline to assist sponsors conducting clinical trials on medicinal products intended to treat gout.

Gout, an inflammatory arthritis brought on by the introduction of monosodium urate crystals within a patient's joints and tissues, is currently estimated to affect 3.9% of adults, with nearly three times as many men being affected as women.

In its 14 June concept paper, EMA notes no guideline yet exists to assist sponsors conducting clinical development on gout products, such as those aimed at reducing gout flares. This is problematic considering the scientific advancements in the field of gout product development and the increasing number of patients suffering from gout, explained EMA.

As part of the development of the proposed guideline, EMA says it wants to look at a number of topics, including the assessment of primary endpoints, the necessary duration of studies, the populations to be studied under clinical investigation, study designs, and the assessment of safety and co-morbidities.

Comments on the proposed guideline are due by 30 September 2012.


Read more:

EMA - Concept paper on the need of the guideline on clinical investigation of medicinal products for the treatment of gout


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