Quoted from http://www.pmlive.com/pharma_news/ema_safety_panel_rules_no_change_needed_for_ariads_iclusig_605906
EMA safety panel rules no change needed for Ariad's Iclusig
Positive news comes after blood clot concerns
The European Medicines Agency (EMA) has ruled the continued use of Ariad's cancer therapy Iclusig unchanged in the EU.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) brought an investigation into the safety of Iclusig (ponatinib) to a close late last week, concluding that there was no need to reduce the approved dose of the drug.
Iclusig was approved in the US and EU last year for the treatment of adult patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), but quickly ran into problems after it was linked to an increased risk of blood clots.
The safety concerns culminated in the drug being temporarily withdrawn from the market in the US and placed under a clinical hold - suspending all clinical trials of the drug - which prompted Ariad to slash its workforce. Around the same time, the EMA announced it was also reviewing the safety of the drug but would allow it to remain on the market in the meantime.
The FDA allowed Iclusig back on the market in January, subject to certain restrictions and a comprehensive Risk Evaluation and Mitigation Strategy (REMS), while the EMA concluded last November it could stay on the market provided it was not prescribed to patients with a history of heart attack or stroke.
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