EMA publishes updated diabetes guidelines
pharmafile | July 2, 2012 | News story | Research and Development, Sales and Marketing |Â Â Avandia, EMA, GSK, R&D, TakedaÂ
The European Medicines Agency has published new guidance on what it wants to see from firms submitting new diabetes treatments.
Specifically, the European regulator is giving new guidance on the clinical studies it will require to support the authorisation of new medicines for treating or preventing diabetes.
From 15 November the EMA will want more information on the long-term safety of anti-diabetes medicines, particularly the addition of a new section on cardiovascular safety.
The updated guidelines also include more specific and up-to-date information on studies in children.
The section on complications of diabetes has been removed from the guideline for the time being, as it still needs ‘substantial revision’, the EMA said.
It added that new sections on the prevention or delay of the onset of type I or type II diabetes and on preservation of beta cell function in patients with type I diabetes have also been added to the guidelines, but notes that experience in these areas is limited.
There have been a number of diabetes drugs that have came under scrutiny because of their side effects, notably on the cardiovascular system and increasing the risk of certain cancers.
These include GSK’s Avandia and Takeda’s Actos, with the former being removed completely from Europe in 2010, and the latter given further safety warnings after it was found to increase the risk of bladder cancer.
The EMA hopes that shoring up its guidelines on new diabetes drugs will lead to safer medicines in this class, and greater public confidence in diabetes treatments.
This is an update from its previous guidance published in 2002, and because of the complexity of the update it went through two rounds of public consultation, one in 2010 and another in 2011.
The final publication was finalised by the CHMP and the Efficacy and Cardiovascular Working Parties.
Ben Adams
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