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Alzheimer’s drug Leqembi backed by FDA expert panel for full approval

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Breakthrough Alzheimer’s drug Leqembi has received the unanimous support of a US Food and Drug Administration advisory panel – all but ensuring full approval for the first of its class treatment.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 6-0 that data showed Leqembi – also known as lecanemab – demonstrated a clinical benefit to patients.

The PCNS came to its decision after reviewing evidence from a Phase 3 Clarity AD clinical trial that showed Leqembi slowed cognitive and functional decline in patients by 27% compared to a placebo at 18 months.

The FDA will decide on July 6 whether to endorse the drug made by Japanese pharmaceutical company Eisai and Massachusetts-based global biotechnology firm Biogen.

Leqembi received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023 and was launched in the US on January 18 this year.

The accelerated approval which allows for faster consent for drugs for serious conditions that fill an unmet medical need, was based on Phase 2b data that demonstrated that Leqembi reduced the accumulation of amyloid-beta plaque in the brain, a neuropathological hallmark of Alzheimer’s disease.

But this approval restricted Leqembi, which is administered twice a month intravenously, to patients who could either pay $26,500 a year or, in the case of the US Government’s Medicare national health insurance programme for seniors and the disabled, to those who were enrolled on a clinical trial. This even though there are no clinical trials underway.

However, FDA approval would mean that Leqembi would become more readily available through Medicare with the agencies running the programme, The Centers for Medicare and Medicaid Services (CMS), having promised to broadly cover the cost of the drug for patients who are willing to take part in a national data registry to track “evidence about how these drugs work in the real world.”

But that listing has yet to be created and the US-based Alzheimer’s Association has described making registry a condition of coverage an “unnecessary and potentially harmful barrier.”

Joanne Pike, the Alzheimer’s Association’s president and CEO, said: “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks.

“Now all eyes turn to CMS. Medicare is supposed to be a rock-solid guarantee for Americans, and it is time for CMS to step up and provide Medicare access on the day of an FDA traditional approval.

Alzheimer’s drug Leqembi. Image: Eisai Co.

“Americans living with Alzheimer’s disease deserve access to FDA-approved therapies without barriers, just like people with cancer, heart disease and HIV/AIDS.”

According to the Alzheimer’s Association, 6.5 million Americans are currently living with the disease, which robs patients of their memory and causes other cognitive problems.

The organisation says Alzheimer’s and other dementias will cost the US $345bn this year. That cost is predicted to rise to $11bn annually by 2050 as more people are diagnosed with the condition.

Leqembi, which is an anti-amyloid treatment, changes the course of Alzheimer’s and has been shown to deliver clear clinical benefit for people in the early stages of the disease.

By slowing progression in the early stages of Alzheimer’s, the treatment will give people more time to participate fully in daily life, help make important decisions, and live independently.

This could mean more time for a person to take care of family finances, and engage in hobbies and interests.

Phase 3 data from the Clarity AD global clinical trial published in the New England Journal of Medicine showed Leqembi met both the primary and all key secondary endpoints for the patient population with highly statistically significant results.

As with other anti-amyloid treatments in this class of drugs, Leqembi does have side effects, including brain swelling and bleeding.

Three deaths from brain haemorrhages occurred in the extended part of the trial. The FDA said the patients had a disorder called cerebral amyloid angiopathy, which is the build up of amyloid in small arteries and capillaries in the brain, a condition that can be difficult to detect by imaging tests.

Despite this, Dr Pike has welcomed the FDA Advisory Committee’s decision. She said: “The Alzheimer’s Association welcomes and celebrates this action by the FDA Advisory Committee to support traditional approval of Leqembi for people with early Alzheimer’s.

“With this action we are one step closer to more people living with Alzheimer’s having more time with more of their capabilities intact – to do the things they want to do and love to do best.”

Myra Garcia, a member of the Alzheimer’s Association Early Stage Advisory Group, spoke to the committee hearing and said: “While the thought of a cure for Alzheimer’s disease is certainly part of my optimism, I’d like you to know that for me, more time is enough for now. And that is the promise of treatments like lecanemab.”

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Tai chi outperforms conventional exercise for seniors

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New findings from 12 studies involving 2,901 participants have demonstrated that tai chi outperforms conventional exercise in improving mobility and balance in seniors.

While tai chi is understood to be beneficial for functional mobility and balance in older adults, such benefits are not well understood due to large variance in research study protocols and observations.

This new review and analysis has now shown that tai chi can induce greater improvement in functional mobility and balance in relatively healthy older adults compared to conventional exercise.

The findings showed the following performance results:

  • The time to complete 50-foot walking was 1.84 seconds faster. 
  • The time to maintain a one-leg stance was 6 seconds longer when eyes were open and 1.65 seconds longer when eyes were closed. 
  • Individuals improved their timed-up-and-go test performance by 0.18 points, indicating quicker standing, walking, and sitting.
  • Individuals taking the functional reach test showed significant improvement with a standardised mean difference of 0.7, suggesting a noteworthy positive impact on the ability to reach and perform daily activities.

Secondary analyses revealed that the use of tai chi with relatively short duration of less than 20 weeks, low total time of less than 24 total hours, and/or focusing on the Yang-style of this ancient form of Chinese martial arts were particularly beneficial for functional mobility and balance as compared to conventional exercise.

“This systematic literature review and meta-analysis are exciting because they provide strong evidence that tai chi is a more efficient strategy to improve functional mobility and balance in relatively healthy older adults, as compared to conventional exercise,” said Brad Manor, Ph.D., director of the Mobility and Falls Program at Hebrew SeniorLife’s Hinda and Arthur Marcus Institute for Aging Research, and associate professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center.

“This research suggests that tai chi should be carefully considered in future studies and routines of rehabilitative programs for balance and mobility in older adults,” said Bao Dapeng, professor at Beijing Sport University.

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New standards for biomarkers of ageing

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A paper has put forward a new framework for standardising the development and validation of biomarkers of ageing to better predict longevity and quality of life.

Led by Harvard researchers, the team has zeroed in on biomarkers of ageing using omic data from population-based studies. 

The team included ageing and longevity expert Alex Zhavoronkov, PhD, founder and CEO of AI-driven drug discovery company Insilico Medicine, and the findings appeared in Nature Medicine

Ageing is associated with a number of biological changes including increased molecular and cellular damage, however, researchers do not yet have a standardised means to evaluate and validate biomarkers related to ageing. 

In order to create those standards as well as actionable clinical tools, the team analysed population-based cohort studies built on omic data (data related to biological molecules which can include proteomics, transcriptomics, genomics, and epigenomics) of blood-based biomarkers of ageing. The researchers then compared the predictive strength of different biomarkers, including study design and data collection approaches, and looked at how these biomarkers presented in different populations. 

In order to better assess the impact of ageing using biomarkers, the researchers found that clinicians needed to expand their focus to consider not only mortality as an outcome, but also how biomarkers of aging are associated with numerous other health outcomes, including functional decline, frailty, chronic disease, and disability. They also call for the standardisation of omic data to improve reliability. 

“Omics and biomarkers harmonisation efforts, such as the Biolearn project, are instrumental in validation of biomarkers of aging” said co-first author Mahdi Moqri, PhD, of the Division of Genetics. 

Biolearn is an open-source project for biomarkers of aging and is helping to harmonise existing ageing biomarkers, unify public datasets, and provide computational methodologies.

The team also emphasised the importance of continued collaborations among research groups on “large-scale, longitudinal studies that can track long-term physiological changes and responses to therapeutics in diverse populations”, and that further work is required to understand how implementation of biomarker evaluation in clinical trials might improve patient quality of life and survival.

“If we hope to have clinical trials for interventions that extend healthy lifespan in humans, we need reliable, validated biomarkers of ageing,” said co-first author Jesse Poganik, PhD, of the Division of Genetics. 

“We hope that our framework will help prioritise the most promising biomarkers and provide health care providers with clinically valuable and actionable tools.”

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Healthy aging research to receive $115 million

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Global non-profit Hevolution Foundation has announced $115 million in funding that makes up 49 new awards under its Geroscience Research Opportunities (HF-GRO) programme.  

As part of Hevolution’s mission to catalyse the healthspan scientific ecosystem and drive transformative breakthroughs in healthy aging, HF-GRO is funding promising pre-clinical research in aging biology and geroscience. 

Through this first wave of HF-GRO awards, Hevolution will invest up to $115 million in this first cohort of 49 selected projects over the next five years. Its second call for proposals under HF-GRO will be announced later this year, offering an additional $115 million to address the significant funding gaps in aging research.  

Dr. Felipe Sierra, Hevolution’s Chief Scientific Officer stated: “These 49 important research projects represent a significant step forward in deepening our understanding of healthy aging. Hevolution’s prime objective is to mobilise greater investment around uncovering the foundational mechanisms behind biological aging. 

“We are steadfast in our belief that by examining the root causes of aging, rather than solely focusing on its associated diseases, we can usher in a brighter future for humanity.” 

HF-GRO awardees include researchers at prestigious institutions across the United States, Canada, and Europe, including the U.S. National Institute on Aging, Brigham and Women’s Hospital, the Buck Institute, the Mayo Clinic, New York University, and the University of California San Francisco, among many others. 

The American Federation for Aging Research is providing programmatic support for the HF-GRO program, with grantees selected through a rigorous two-stage peer-review process involving 100 experts in aging biology and geroscience. 

Dr Berenice Benayoun, an HF-GRO grant recipient at the University of Southern California, stated: “I am extremely honored and excited that Hevolution selected our project for funding. This is a project close to my heart, which aims at understanding why and how the female and male innate immune aging differs. 

“This funding will support us as we start laying the foundation for a lasting improvement of women’s health throughout aging.” 

To date, Hevolution has committed approximately $250 million to transform the healthy aging sector, including the $40 million for specialised research and development in healthspan science recently announced at Hevolution’s Global Healthspan Summit. 

Hevolution is ramping up its investments to enable healthier aging for all and is now the second largest funder of aging biology research worldwide.  

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