Parkinson's UK meets with UK regulatory agency to discuss upcoming repurposing trial
This week key colleagues from Parkinson's UK met with the UK Medicines and Healthcare products Regulatory Agency (MHRA) along with colleagues from University College London and the British Generics Manufacturers Association (BGMA).
We met to discuss an upcoming trial of a drug, funded through the Parkinson's Virtual Biotech, which we hope to repurpose to help manage an important but unmet symptomatic need for people with Parkinson's.
Arthur Roach, Director of Research at Parkinson's UK, comments:
"The discussion with the MHRA was very constructive, and the expert advice we received will help us to consider how our trial can be designed to achieve its full potential.
"Repurposing drugs that are already in use for other conditions to treat Parkinson's is an exciting area. There have already been a number of trials carried out with a wide range of existing drugs in the last decade. However, most of these trials have had limited or no impact on common clinical practice, because even when the results are positive they do not lead to a formal approval by government regulators. This approval is important to patients, doctors and health care systems like the NHS, because it determines through a rigorous, independent and professional review process if the available evidence shows the drug to be safe and effective for its planned use.
"Here in the UK we have worked out a new path by which this approval, by the MHRA, can be obtained for a repurposed, off-patent drug by the collaborative efforts of researchers, the BGMA, the NHS and charities like Parkinson's UK.
"This is pioneering work. These discussions are about driving forward better treatments for Parkinson's as rapidly and efficiently as possible. By bringing together the key stakeholders we are looking to create a clear route forward for this repurposed drug to be approved for use should our trial be successful so that it can be made available to people with Parkinson's."