The European Medicines Agency (EMA) on Thursday released a draft guideline on developing drugs to treat peripheral arterial occlusive disease (PAOD) of the lower extremities.
The guideline states that lower extremity ischaemic disease (LEAD) is the most common clinical manifestation of PAOD and is characterized by the obstruction of blood flow within the arteries leading to limb loss or amputation.
The updated document, when adopted, will supersede the current 22-year-old guideline which has been in effect since April 2002. EMA said the goal of the revision is to “explicitly address clinical development of medicinal products intended to treat arterial lower extremity disease, to reflect updates in disease classification and management, including the angiosome concept, but also provide guidance on estimands, definition of clinical endpoints, and cover specific aspects related to the clinical development of advanced medical therapies (ATMPs) in the setting of lower extremity arterial disease.”…
