Clinical trials into potential heart drug halted over Brexit fears


Clinical trials into a potential heart drug have been halted due to fears over Brexit, it has been reported. 

US-based research firm Recardio was due to begin a study of the drug dutogliptin on patients in Exeter, Leeds and Clydebank.

However, it has now suspended the UK arm of the trial over concerns about how new medicines will be approved after Brexit, the BBC reported.

The Government today said it is ‘confident’ Britain will still be able to deliver the ‘best possible environment’ for clinical trials after Brexit.

Britain’s future after leaving the EU remains uncertain, as Prime Minister Theresa May continues to work towards a deal with the bloc.

Recardio’s trial is also running in hospitals in Poland, Austria, Belgium, Bulgaria, Hungary, the Netherlands, Poland and the US.

New drugs intended for use in the EU are evaluated by the European Medicines Agency (EMA), based in London.

The EMA is seeking to relocate to new headquarters in a different EU country after Brexit.

A spokeswoman for the Department of Health said: ‘We are confident of reaching a deal with the EU that benefits patients and continues to deliver the best possible environment in which to support clinical trials.

‘We want to ensure that patients in the UK and across the EU are still able to access the most innovative and effective medicines.’

Recardio’s founder and president, Dr Roman Schenk, told the BBC that uncertainty over Brexit had created a ‘very difficult’ situation for his company.

The Golden Jubilee National Hospital, near Glasgow, was told the position of Recardio, based in California, could change ‘when the regulatory situation has clarity’, PharmaPhorum reports.

The UK Clinical Trials Gateway states the firm is ‘not recruiting’ participants for the double-blind phase two study in the UK – despite it supposed to having been started back in April. 

The trial is hoped to uncover that dutogliptin can be used safely alongside filgrastim to repair heart tissue in heart attack patients.

Britain’s deadline to leave the EU is March 2019, however fears have mounted in recent weeks that it will crash out of the bloc without a deal.

Brussels has dismissed parts of Theresa May’s proposed terms, stating that the Prime Minister cannot ‘cherry-pick’ terms Britain will agree to.

If the EU and Britain fail to reach terms, it could scupper plans of a 21-month transition period after officially leaving the bloc.

It comes after it was reported last month the NHS will be franchised around the world under controversial plans to raise £7 billion in the aftermath of Brexit.

Officials said they hoped the money-making move will allow trusts and NHS boards to pump their profits directly into swamped frontline services.

Britain’s main supplier of insulin also warned last month it was stockpiling the medicine in case Brexit disrupts the supply chain.

Around 4.6 million people in the country are thought to have diabetes and many of them rely on insulin to stay healthy.

Danish healthcare company Novo Nordisk supplies more than half of the UK’s insulin and revealed it’s importing enough of the vital medication to last four months.

Leading medics have repeatedly warned a no deal Brexit could be ‘catastrophic’ for the NHS. 

The British Medical Association, the union for doctors, in August said failing to agree trade terms could deepen the NHS workforce crisis and disrupt millions of patients.


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