The manufacturer of lecanemab, an investigational drug for early Alzheimer’s disease (AD), has submitted a marketing authorisation application to the Medicines and Healthcare products Regulatory Agency (MHRA).
In a press release issued on 22 May 2023, Eisai said that the MHRA had placed the drug under its Innovative Licensing and Access Pathway (ILAP), which is intended to speed up a drug’s time to market.
Lecanemab, which is aimed to target and clear the build-up of amyloid protein within the brain, received Food and Drug Administration approval in the United States in January 2023 under an accelerated pathway.
The application to the MHRA follows phase III and phase IIb studies, results of which show that the drug can reduce clinical decline in early AD.
Commenting on early results from the phase III trial in September 2022, Susan Kohlhaas, director of research at Alzheimer’s Research UK, described it as “a historic moment for dementia research”.
An additional phase III clinical trial is ongoing; however, some side effects — including headaches and brain swelling — were experienced by some trial participants, with 17% of those who received lecanemab reporting headaches.
David Thomas, head of policy at Alzheimer’s Research UK, said: “We want to see the MHRA reach an evidence-based decision on lecanemab’s safety and efficacy as a matter of urgency. The COVID-19 vaccine taskforce showed how this can be a rapid process, without compromising quality or rigour. It’s time to apply these lessons to the next healthcare crisis of our time — dementia.
“With lecanemab already having accelerated through the United States’ approval process, this is now an important test of the UK government’s commitment to being a ‘science superpower’ and ensuring post Brexit that people in the UK are among the first in Europe to benefit from much needed new treatments in dementia.
“People [in the UK] with AD and their families deserve effective new treatments and, should lecanemab be approved, it would be the first new Alzheimer’s drug here for nearly 20 years.”