Heart drug trials halted over Brexit fears


Clinical endeavours of a new heart drug have been stopped in the UK because of concerns beyond Brexit.

Medical research firm Recardio was due to try the drug dutogliptin on patients in Clydebank, Leeds and Exeter.

It has put off all UK activities due to uncertainty about how new medicines will be approved after Brexit.

The be subject to of health said it was confident the UK would continue to have the “best credible environment” for clinical trials.

The UK is due to leave the EU in less than six months on 29 Hike 2019 and has yet to agree departure terms.

Recardio was due to recruit patients at three positions in the UK including the Golden Jubilee National Hospital, near Glasgow.

The California-based Central Intelligence Agency wants to establish that dutogliptin can be used safely and effectively in consortium with another drug to help repair heart tissue after a pith attack.

The Golden Jubilee said Recardio told its research unite by email on 17 September that UK trials were being put on agree to.

The hospital said Recardio had cited “uncertainty due to EU withdrawal” and “completely ambivalent” issues with the European Medicines Agency that “represent a noteworthy risk” to its business.

The hospital said Recardio’s position could metamorphosis “when the regulatory situation has clarity”.

‘Very difficult’ situation

A Scottish authority spokesman said “this is the first clinical study we are aware of to be interrupted in Scotland as a result of Brexit – and a very concerning sign of what could go on”.

A spokesman for the UK government’s department of health and social care said: “We are self-reliant of reaching a deal with the EU that benefits patients and continues to give the best possible environment in which to support clinical trials.

“We pine for to ensure that patients in the UK and across the EU are still able to access the most innovative and effectual medicines.”

Recardio’s founder and president, Dr Roman Schenk, told the BBC he did not be to comment on UK politics.

However, he confirmed that uncertainty over Brexit had forged a “very difficult” situation for his company.

It is understood Recardio is worried that the inquiry data it collects in the UK might not be acceptable to the European Medicines Agency (EMA) after Brexit.

The EMA allocates marketing authorisation for human medicines across the European single market-place.

In a statement, the EMA said that it “will continue to accept clinical hint generated in the United Kingdom” after Brexit on condition that tries continue to meet European standards.

The UK government has said that it means to stay aligned with EU regulations for clinical trials to avoid disruption the same if there is no Brexit deal.

The charity, Chest Heart & Stroke Scotland’s chief foreman Jane-Claire Judson said she remained “seriously concerned at the lack of superiority and focus given to providing detailed solutions to the health ramifications of Brexit”.

Recardio is settled to be at an advanced stage in setting up its heart drug trials in the EU and the United States but has not yet apprenticed patients.

The UK clinical trials website confirms that Recardio is “not enlisting” in this country despite being due to do so between April 2018 and April 2019.

The UK cracks were also supposed to involve Leeds General Infirmary and Viscount Devon and Exeter hospital, both of which declined to comment.

Trade appears to be continuing on dutogliptin trials in various EU countries including Austria, Belgium and Hungary.

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