Biogen and Eisai’s Alzheimer’s disease (AD) drug has shown continued benefits in patients with early stages of the neurodegenerative disease, according to three-year data presented at this year’s Alzheimer’s Association International Conference.

Leqembi (lecanemab-irmb) was granted traditional US approval in July 2023 for use as an intravenous infusion in patients with mild cognitive impairment or early-stage AD.

The US Food and Drug Administration’s decision was supported by data from the phase 3 confirmatory Clarity AD clinical trial, and Eisai has now presented positive results from an open-label extension of the study.

The latest data showed that more than 50% of patients receiving continuous Leqembi treatment showed ongoing improvement over three years, with a -0.95 decline on the CDR-SB cognition rating scale.

The companies noted that a change from 0.5 to one on the CDR is “the difference between slight impairment and loss of independence”, such as the ability to be left alone, remember recent events and participate in daily activities.

Additionally, no new safety findings were observed with continued Leqembi treatment over three years.

The US Food and Drug Administration (FDA) has announced plans to establish a new innovative hub aimed at improving treatment options for rare disease patients.

The Rare Disease Innovation Hub will leverage cross-agency expertise to expedite the development and approval of safe and effective drugs and biologics.

Co-led by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research (CDER), the hub will have a particular focus on products intended for smaller populations or for diseases where the natural history is “variable and not fully understood”.

Its three main functions will include serving as a single point of connection and engagement with the rare disease community for matters that intersect CDER and CBER, including medical devices and combination products; and enhancing inter-centre collaboration to address scientific, clinical and policy issues relating to rare disease product development.

It will also aim to advance regulatory science with “dedicated workstreams for consideration of novel endpoints, biomarker development and assays, innovative trial design, real-world evidence and statistical methods”, according to Marks and Cavazzoni.

New figures published by the NHS have revealed a record number of people living in England being diagnosed with dementia.

Currently, England has one of the highest dementia diagnosis rates in the world, with the latest NHS figures showing a record of 487,432 people in England being diagnosed with the neurodegenerative disorder as of June.

Since the beginning of the COVID-19 pandemic in 2020, dementia diagnosis rates have been at their highest of 65% and, according to the latest figures, 86,434 people diagnosed with dementia had their medication reviewed in the preceding 12 months, compared to 77,112 in June 2023.

However, around a third of those living with dementia in England do not have a diagnosis and the NHS intends to meet its ambition to diagnose 66.7% of the total number of people that estimates suggest are living with a form of the condition.

In an effort to achieve this, the NHS is encouraging timely diagnosis for dementia and is proactively assessing care home residents to support identification of people who may have dementia to increase the number of patients who are diagnosed.

The UK government has announced a national vaccination programme to protect infants and older adults against respiratory syncytial virus (RSV).

The rollout will make the UK the first country worldwide to have a national programme that uses the same vaccine, Pfizer’s Abrysvo, to protect both age populations against the common respiratory virus.

The scheme will begin in September in England, Wales and Northern Ireland, while Scotland was due to start the vaccinations in August.

RSV is characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, it can cause severe illness such as bronchiolitis and pneumonia in certain groups, including young infants and older adults.

Approximately 30,000 hospitalisations in children aged under five years and 9,000 hospital admissions in those aged over 75 years are caused by RSV every year in the UK.

The new initiative will include a vaccine for pregnant women over 28 weeks to help protect their babies, a routine programme for those aged over 75 years and a one-off campaign for people aged 75 to 79 years.