EMA in new Iclusig probe
pharmafile | December 9, 2013 | News story | Sales and Marketing | Ariad, EMA, iclusig, leukaemia
Europe’s medicines regulator has begun a new review of Ariad Pharmaceuticals’ leukaemia drug Iclusig, looking in particular at the risk of blood clots or blockages in the arteries.
The EMA’s action was prompted by concerns that patients have been suffering such events at a higher rate than was the case when Iclusig (ponatinib) was originally authorised.
The drug has already been suspended in the US because of worries over safety, although Europe seems to have been taking a more relaxed stance.
But this is not to say the EMA is unaware of the risks: last month the regulator allowed its use to continue but with restrictions which include a warning against Iclusig treatment in patients who have had a heart attack or stroke in the past.
It also now recommends that all patients be assessed for cardiovascular risk, with treatment stopped immediately in anyone with signs of a blockage in the arteries or veins.
But the EMA still believes there are questions to answer. “A number of issues required further investigation,” it said in a statement.
These include trying to get a better understanding of the nature, frequency and severity of events obstructing the arteries or veins, how the drug produces these side effects – and whether this means there is a need to revise the dosing recommendation for Iclusig.
The review – triggered by the European Commission, under EC 726/2004 – will be conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which will then make recommendations to the CHMP.
The CHMP’s opinion will go forward to the European Commission for a legally binding decision.
In October Ariad was forced by the FDA to suspend sales of Iclusig given the high risk of blood clots from the medicine.
The drug was authorised by the US regulator at the end of last year and has licences to treat two rare blood cancers: a type of chronic myeloid leukaemia (CML) and a version of acute lymphoblastic leukaemia.
The FDA passed the drug under an accelerated approval, which is granted based on promising data from early trials but the process still requires further studies to prove the drug is as effective as initially thought.
If the drug is not as effective or deemed unsafe in follow-up studies, the regulator can pull or suspend the treatment, as the FDA has done here.
Ariad has also stopped an ongoing trial of the drug because of the same safety concerns, mutually agreeing with the FDA that its Phase III EPIC trial should be terminated because patients treated with Iclusig suffered arterial thrombotic events.
The study was suspended before being scrapped completely and the 300 or so patients from EPIC are now being removed from treatment.
This – and the new probe by the EMA – are worrying for Ariad, which had been bullish about the drug’s prospects at the beginning of the year. Analysts said it could generate sales of about $821 million by 2018.
It works by bypassing T315I, the so-called ‘gatekeeper’ mutation in CML which has been associated with resistance to other approved treatments – and Ariad was confident that its mode of action is different from tyrosine kinase inhibitors such as Novartis’ Glivec, Tasigna and Bristol-Myers Squibb’s Sprycel.
Adam Hill
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