english.prescrire.org > Topics > Advancing healthcare policy > Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, MA (10/2016)
Advancing healthcare policy

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients.
 

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Antidiabetic drugs: demand clinical endpoints that are useful to patients, and evaluate risks before, not after, market authorisation (October 2016)

In its response to an EMA consultation, Prescrire underscores the importance of evaluating the efficacy of antidiabetics using clinical endpoints useful to patients, and of evaluating their risks properly, in particular their cardiovascular risks, before authorisation rather than afterwards. Read on...
 


Paris, 31 October 2016

Summary

The European Medicines Agency (EMA) has released a concept paper for public consultation on the revision of its guideline on the clinical evaluation required to apply for European marketing authorisation for antidiabetic drugs. In its response to this consultation, Prescrire reminds the EMA of the importance of evaluating the efficacy of antidiabetics using clinical endpoints useful to patients, and of evaluating their risks properly, in particular their cardiovascular risks, before authorisation rather than afterwards.

> Click here to download Prescrire's response to the consultation (pdf, 243 Ko)
 

©Prescrire October 2016