Hope for the first drug licensed in the UK specifically for Lewy body dementia has received a significant boost after neflamapimod was awarded a UK Innovation Passport.
The Lewy Body Society welcomes the decision, which gives neflamapimod entry to the Innovative Licensing and Access Pathway (ILAP).
The pathway supports promising medicines that could address a major unmet clinical need and helps developers navigate the route from clinical trials to potential NHS use.
Jacqui Cannon, Chief Executive of the Lewy Body Society, said: “Lewy body dementia is the second most common progressive dementia in older people in the UK, yet it remains poorly understood and is often misdiagnosed. It is encouraging for the Lewy body dementia community to see an investigational treatment for this devastating disease included in a program like ILAP.
“We are hopeful that the coordination between the Medicines and Healthcare products Regulatory Agency, the Health Technology Assessment bodies, and the NHS can bring us closer to patients having access to the UK’s first approved treatment for Lewy body dementia.”
No medicine is currently licensed in the UK specifically for Lewy body dementia. People are often prescribed medicines developed for Alzheimer’s or Parkinson’s disease to manage some of their symptoms.
Neflamapimod is being developed as a potential disease-modifying treatment. It targets processes linked to inflammation and impaired communication between nerve cells in the brain, with the aim of slowing the progression of Lewy body dementia rather than only managing its symptoms.
Whether it can achieve this has not yet been established, and further clinical trials are needed. CervoMed, the biotechnology company developing neflamapimod, is preparing for a planned Phase 3 clinical trial.
The Innovation Passport is the entry point to the UK’s Innovative Licensing and Access Pathway. It is awarded to medicines that could address an unmet clinical need and have the potential to offer significant benefits to patients.
Through the pathway, CervoMed will be able to work earlier and more closely with the MHRA, the NHS and the bodies responsible for assessing whether new treatments should be made available through the health service.
These include the National Institute for Health and Care Excellence, the Scottish Medicines Consortium and the All Wales Therapeutics and Toxicology Centre.
This coordinated support can help the developer plan clinical trials, understand what evidence regulators and health services will need, and prepare for how a treatment could be introduced into NHS care. Addressing these questions while the medicine is still being developed may reduce unnecessary delays later.
Innovation Passport holders can also receive priority access to services supporting clinical trial delivery, scientific advice, regulatory assessment and preparation for NHS adoption.
The award is an important recognition of both neflamapimod’s potential and the urgent need for better treatments for Lewy body dementia. It does not mean that the drug has been approved. Any future availability will depend on clinical evidence showing that it is safe, effective and offers value to patients and the NHS.
