Explore options for making NurOwn available to treat Motor Neurone Disease (MND)
- Parliament:
- 2019–24
- Signatures:
- 65,433
- Responded:
- 7 May 2020
- Department:
- Department of Health and Social Care
The petition
No effective treatment exists for 5,000 sufferers of MND in the UK. NurOwn is in the final months of Phase 3 of a US FDA regulated clinical trial. Phase 2 data indicated NurOwn was safe and demonstrated signs of efficacy at low doses.
The Government should explore options for making NurOwn available to treat MND. Either early availability / approval of is sought or access to treatment that, at the latest, coincides with FDA approval. An Accelerated Access Review (AAR), Accelerated Assessment (MHRA), Accelerated Access Collaborative (NICE), a clinical trial and collaboration between the NHS and drug company are different means of expediting availability and access to NurOwn for the treatment of MND in the UK.
Inclisiran is a drug that in January 2020 had not yet been approved in the UK or EU. In January the Secretary of State for Health and Social Care approved one of the world's largest drug trials in a collaboration between Novartis and the NHS, with the latter funding and overseeing treatment.
The government's response
The Government recognises the devastating effects of motor neurone disease. It is a key priority to provide access to the most effective and innovative medicines and treatments for NHS patients.
We are very sorry to learn about anyone who has been diagnosed with motor neurone disease (MND). We recognise the immense challenges faced by those who are suffering with this truly devastating and incurable disease.
The Government understands how important it is for patients to have access to the most effective medicines and treatments. We are making the NHS one of the most pro-innovation healthcare systems in the world. The NHS Long-Term Plan and the Life Sciences Sector Deals set out a clear vision of a health system which prioritises innovation and delivers faster patient access to life-changing products. The Accelerated Access Collaborative (AAC), brings together the leaders from Government, the NHS and industry to tackle the barriers to the development and adoption of innovation in the UK.
All medicinal products are required to have a marketing authorisation (a licence) before they can be put on the market and given to patients outside of a regulated clinical trial. Licences are given based on a positive benefit/risk assessment by a regulatory authority considering the results of animal studies and data from clinical trials which are designed to show efficacy and safety in humans.
To run a clinical trial, a company will make an application to a regulatory authority (in the UK this is the Medicines and Healthcare products Regulatory Agency), and a research ethics committee, to ensure the clinical trials are conducted appropriately. The company that manufactures NurOwn can choose where to conduct their clinical trials and in this case the company has not conducted one in the UK.