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Ariad’s cancer drug to remain on EU market

But EMA restricts use of Iclusig due to blood clot risk
Ariad Iclusig ponatinib

Ariad's troubled cancer drug Iclusig received a boost in Europe after regulators determined the drug was safe enough to remain on the market.

Iclusig (ponatinib), which was launched in the EU and US earlier this year for two types of leukaemia, has been beset by problems since being linked to an increase in the risk of blood clots.

These have been most harshly felt in the US where the drug is facing a suspension on sales and the termination of clinical trials, leading to the loss of 160 jobs in Ariad's operations in the country.

Shortly after this US suspension, the European Medicines Agency (EMA) announced it was investigating the safety of Iclusig.

Following this investigation, the EMA's Committee on Human Medicinal Products (CHMP) has now recommended that Icuslig be allowed to remain on the market, although with strict restrictions on who is allowed access to the treatment.

According to the CHMP, patients who should not receive Iclusig treatment include those who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks.

The cardiovascular risk of all patients to be treated with Iclusig should also be assessed, and patients with high blood pressure should have their blood pressure controlled. Treatment with Iclusig should be halted as soon as signs of blood clot are detected.

This recommendation will now be sent to the European Commission to confirm the update to Iclusig's product information.

The EMA also 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.

Combined hormonal contraceptives

Other safety measures recommended by the EMA in its latest round of CHMP updates include an update to the product information on combined hormonal contraceptives (CHCs).

CHCs have also been linked to blood clots, or venous thromboembolism, leading to an EMA review of their safety.

However, the CHMP concluded that the benefits of CHC in preventing unwanted pregnancies outweigh their risks, meaning they should be allowed to remain on the market although with updated information to help women make informed decision about their contraception and the risk of VTE.

Thiocolchicoside restricted

In the final EMA safety update, the agency recommended a restriction on the use of thiocolchicoside-containing medicines when given via mouth or injection.

Thiocolchicoside should now only be used an add-on treatment for painful muscle contractures resulting from spinal conditions and at a restricted dose and length of treatment.

This is due to evidence provided by the Italian medicines agency that suggested the way thiocolchicoside broke down in the body could damage cells, resulting in an abnormal number of chromosomes.

Article by
Thomas Meek

25th November 2013

From: Sales, Regulatory

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