Is Biogen’s new Alzheimer’s drug a breakthrough or false hope?

The Alzheimer's Society of Ireland says that there are about 64,000 people living with dementia in the State, an umbrella term it uses for a range of conditions that damage the brain, impairing memory, thinking processes and the ability to live independently and carry out everyday tasks. Alzheimer's disease is the most common cause.

The figures are frightening. The group reckons 11,000 people a year will be diagnosed with dementia – that’s more than 30 every day. With Ireland’s population ageing, the society estimates the figure will more than double to 150,000 within 25 years.

And there’s no cure.

No wonder patients and their families are so desperate for good news.

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So it was no surprise to see shares in pharma group Biogen rocket 50 per cent on Monday after an unexpectedly broad approval for its new Alzheimer's drug from the US Food and Drug Administration. It's the first new Alzheimer's drug in almost 20 years and follows years of dashed hopes and failed drug trials.

You would expect to see massive cheer in medical circles at such a breakthrough. Instead, there has been almost universal concern, and even anger, with one expert calling the approval “one of the worst decisions the agency has ever made”, adding that it “eviscerates the... standards for approving new drugs”.

That presumably refers to the almost unanimous recommendation from an expert panel the FDA itself convened to reject the drug, which had previously failed to meet expectations in trials.

The new drug doesn't cure Alzheimer's; it doesn't even stop its progression. It might slow it down. What it does do is remove abnormal protein clumps, called amyloid plaques, from the brain. Much Alzheimer's research in recent years has been focused on the impact of these plaques.

For its part, the FDA said the effect on amyloid is “reasonably likely to predict a clinical benefit”. It has ordered further study to confirm that but it will be years before that produces results.

Meantime, Biogen has slapped a $56,000 (€45,000) price tag for a year's supply of the medicine, to be called Aduhelm. That's more than twice the highest-price forecast of industry analysts.

There is, of course, no certainty that the European Medicines Authority will follow the lead of the FDA, especially in light of the controversy it has raised. And even if it does, there is little chance that the drug would become available in Ireland at anything close to that price.