Ariad gets positive CHMP opinion for continued Iclusig (ponatinib) availability

The CHMP recommends that Iclusig should not be used in patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks. In addition, the cardiovascular risks of all patients should be assessed and measures should be taken to reduce risks before starting and during treatment with Iclusig. Patients who have high blood pressure should have their blood pressure controlled, and treatment with Iclusig should be stopped immediately in any patient with signs of blood clots obstructing arteries or veins. Further details on these recommendations can be found below.

The CHMP’s recommendations follow a review of updated clinical trial data indicating that blood clots were occurring at a higher rate than was observed at the time of the medicine’s initial authorisation. Conditions related to blood clots, such as heart attacks and strokes, were already considered to be possible side effects of Iclusig and were listed in the EU product information.

Since the medicine’s initial approval in July 2013, its use has been limited to patients who could not be treated with other medicines of the same class, for example, because patients were intolerant to the other medicines or their disease was resistant to them.

The CHMP recommendations are broadly in line with previous advice of the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) and an opinion will be sent to the European Commission for an update of the EU product information.

The Agency now plans to conduct a further in-depth review of relevant data on the benefits and risks of Iclusig and will make recommendations on whether there should be further changes to how the medicine is used.

Full press release here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2...