California-based clinical stage pharmaceutical company Recardio has halted its UK activities due to concerns over Brexit and how it will impact the approval of medicines.
Recardio started recruiting in April for a Phase II trial of its dutogliptin in combination with filgrastim for early recovery post-myocardial infarction in three locations in the UK: Clydebank, Leeds and Exeter, as well as 26 other centres in the European Union (EU). Dutogliptin is a novel approach to restoring lost myocardial function following an ST-Elevation myocardial infarction, a heart attack causes by a complete blockage in the coronary artery.
The UK Clinical Trials Gateway notes the company’s study as ‘not recruiting’ despite the trial being registered until April 2019, whereas the EU’s register lists Recardio’s trial into dutogliptin as ongoing, with no results.
The company’s moves suggests it is concerned that any research data it collects in the UK might not be applicable for European Medicines Agency (EMA) consideration after Brexit.
Recardio’s founder and president Dr Roman Schenk told the BBC that the continuing uncertainty over Brexit had caused his company a lot of difficulty. Recardio did not respond to a request for comment from Pharmaceutical Technology.
The EMA has confirmed to the BBC that it will continue to accept clinical evidence generated in the UK after Brexit if UK trials meet European standards, something the UK government has stated will be met in previous guidance to avoid disruption. However, recent issues between the EMA and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) concern the pharma industry.
In September, the EMA moved to further exclude the MHRA from its drug approval process in preparation for Brexit. This means “[the UK’s] current wealth of regulatory expertise will likely be forced to find new roles, else retrain or migrate,” according to Mathys and Squire Life Sciences Partner Martin MacLean.
This suspension of the UK trial can be reversed at the request of Recardio.