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EMA to review safety of Ariad’s Iclusig

Product information will be updated to warn of blood clot risk
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The European Medicines Agency (EMA) is to review the safety of Ariad's leukaemia drug Iclusig after studies linked it to an increased risk of vascular side effects, such as blood clots.

The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommended an “in-depth review of the medicine's benefit-risk profile” at its November meeting, echoing plans already in place by the US Food and Drug Administration (FDA).

Unlike the US regulator, the EMA did not suspend sales of Iclusig, but instead the PRAC recommended patients and healthcare professionals should continue to use the product with increased caution and monitor patients taking it for evidence of blood clots.

The PRAC also recommend that the product information be updated for Iclusig, which was approved in the EU in July to treat patients with chronic myeloid leukaemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL).

This information should include strengthened warnings on the cardiovascular risk of Iclusig and guidance on optimising the patient's cardiovascular therapy before starting treatment, according to the PRAC.

The recommendations will now be considered by the EMA's Committee for Medicinal Products for Human Use (CHMP), which will then enforce any necessary update.

Iclusig - an orphan medicine - has so far been launched in the EU in Austria, France, Germany, Luxembourg, the Netherlands and the UK, providing another option to patients who had failed treatment with Novartis' Glivec (imatinib) and Tasigna (nilotinib) and Bristol-Myers Squibb's Sprycel (dasatinib).

Upon its approval, the EMA noted some vascular side effects, but new information suggests that these occur at a higher rate than initially thought.

The suspension of sales in the US has already forced Ariad to cut 40 per cent of its workforce in the country. Its European operations have remained unaffected so far, although that may change depending on the EMA's review.

Article by
Thomas Meek

11th November 2013

From: Sales, Regulatory

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