The recent US approval of Biogen’s Alzheimer’s drug highlights the urgent need for a framework for testing and treating a disease that is a “secret pandemic”, according to the head of its Japanese development partner Eisai.
Aducanumab, which will be sold under the brand name Aduhelm, is the first new treatment for Alzheimer’s disease for almost two decades but has attracted controversy in the US for its price tag of $56,000 a year and questions about its effectiveness.
In an interview, Eisai chief executive Haruo Naito said the Japanese group and Biogen were preparing steps to make the drug more widely accessible. But he added that there was a need for countries worldwide to legislate specifically to tackle Alzheimer’s — as the US National Cancer Act did for that disease — to address the high toll on individuals and the annual global cost of dementia, which is now estimated to be more than $1tn.
“We do not think Aduhelm alone will fundamentally treat Alzheimer’s disease, but achieving this milestone will make it possible for us to visualise the path on how we can achieve fundamental treatment,” he said.
According to the World Health Organization, there are almost 10m new dementia cases every year, two-thirds of which are Alzheimer’s disease. Naito said the disease was a “secret pandemic” that was spreading beyond developed countries, such as Japan and the US, to developing nations.
“It’s not just up to one or two pharmaceutical companies but it’s critical to have a much broader public-private framework to combat this disease and there is a sense of frustration that efforts have hardly been made on this front,” he added.
Since the US Food and Drug Administration approved aducanumab, shares in Eisai have risen 45 per cent, with analysts expecting the drug to make a full contribution to earnings from the financial year ending in March 2024.
In addition to the cost of the medicine, Credit Suisse analyst Fumiyoshi Sakai said potential barriers to blockbuster status for the new drug included the difficulty of reaching a definitive diagnosis of Alzheimer’s and the specialised tests required to assess whether a patient is a suitable candidate for the drug. Suitable patients must also then undergo intravenous infusion once every four weeks.
Still, Sakai said the FDA approval had raised the chances of future clearance for Eisai’s BAN2401, another Alzheimer’s drug that is being jointly developed with Biogen. Drugs from rival pharma groups Eli Lilly and Roche may also enter the market earlier than expected.
“Perhaps aducanumab is still in the realm of an experimental drug, but as more data is accumulated over the next few years, it will open the way for other medicine to come out,” Sakai said.
Eisai has been developing medicine to combat dementia since the early 1980s and is best known for Donepezil, the most widely prescribed treatment for Alzheimer’s disease, which was originally developed as Aricept.
“If you look at us from any angle, we’re all about dementia,” Naito, the 73-year-old grandson of Eisai’s founder, said. “We have knowledge that has built up over a long series of failures and we’ve poured in resources that are comparable to Big Pharma, so I feel we are competitive.”