Activists are calling on UK regulators to approve the use of the NHS as the first new treatment for Alzheimer’s disease in nearly 20 years.
Aducanumab, made by manufacturer Biogen, got the green light in the US yesterday.
The drug targets the cause of Alzheimer’s rather than its symptoms, the reports mirror.
It is understood that treatment costs tens of thousands of pounds per patient annually and is only suitable for those in the early stages of the disease, the most common form of dementia.
The director of the UK Dementia Research Institute, Prof. Bart De Strooper, said: “The [US regulator]Aducanumab’s decision to approve aducanumab marks an extremely important milestone in the search for much-needed treatments for Alzheimer’s disease.
“With no effective therapies currently available to stop the progression of this devastating disease, we all hope that this will be a turning point for the millions of people living with this disease.”
Activists in the UK are hoping aducanumab could be offered on the NHS as early as next year, but scientists disagree on Biogen’s study results.
The company’s first study stopped last year when statistical analysis showed the drug had no effect.
But a follow-up study at much higher doses showed a slowdown in cognitive decline in patients, according to Biogen.
The U.S. Food and Drug Administration (FDA) approved aducanumab on condition that another study be done to confirm the treatment’s benefits.
Research firm Edison Group’s managing partner Maxim Jacobs said, “The data was inconsistent and if this was a data package for another disease, I’m not sure it would have been approved.
“There was likely a fair amount of political pressure on the FDA to get the drug approved.”
Dr. Richard Oakley, Director of Research, Alzheimer’s Society, said, “It is encouraging to see aducanumab receive approval for use in people with early-stage Alzheimer’s disease – the first drug to be approved by US regulators in nearly twenty years.
“We are awaiting the opinion of the European Medicines Agency and the outcome of every application to the UK regulatory authorities to provide clarification to people with early-stage Alzheimer’s in the UK.
“We have seen tremendous strides in the last decade leading to this decision today, but we need to keep the momentum going.”
The treatment is given as an infusion every four weeks and targets a toxic protein called amyloid that builds up in the brains of Alzheimer’s patients.
It uses a man-made antibody designed to attach to and destroy amyloid plaques.
The only other drugs currently available provide temporary symptom relief in some patients – and the last was developed 17 years ago.
Prof. John Hardy, neuroscientist at University College London, said: “While I am pleased that aducanumab has received approval, we must understand that this is, at best, a drug of marginal benefit that is only available to very carefully selected patients will help.
“You couldn’t call this the beginning of the end of Alzheimer’s disease, but the end of the beginning of treatments.”