Announcement: Regulating the Future of Healthy Longevity Therapies
Richard Barker announced his new global working group on healthy longevity regulation during a major conference at the Lithuanian Parliament — a pivotal step in bridging innovation and policy.
One of my 10 Wicked Issues in Healthy Longevity framework — and one that is overdue for attention — is the gap between current regulatory processes and the criteria we will need for future healthy longevity therapies.
As we all know, today’s pharmaceutical regulations are designed to assess benefit versus risk for disease treatments, ranging from mild infections to life-limiting cancers. They were never designed to evaluate preventive interventions, with a few exceptions such as anti-hypertensives and lipid-lowering therapies.
Aging per se is not regarded as a disease, and therefore the therapies in development that are expected to slow or reverse the aging process — such as senolytics and epigenetic reprogramming molecules — are being pursued for specific age-related conditions. These range from the relatively common, like sarcopenia, to the more unusual, such as non-arteritic anterior ischemic optic neuropathy. The hope is that these medicines will be approved for recognised diseases and subsequently made available for a wider range of age-related conditions — or for aging itself.
However, one of the most promising developments that could shed light on this situation is the case of GLP-1 receptor agonists, such as Wegovy and Mounjaro. These medicines were originally trialled and approved to treat diabetes, later extended to obesity, and have since been shown to slow inflammation, neurological decline, and a growing list of age-related diseases. Some have even begun to describe them as anti-aging therapies.
Personally, I think it is a small step from this development to recognising medicines that slow aging as a prime risk factor for chronic disease. For this to be acceptable to regulators, we will need well-characterised and broadly accepted risk markers — comparable to BMI for weight loss or blood pressure for anti-hypertensives. Some of this thinking has already been incorporated into the long-delayed TAME trial on metformin, and I believe a focused effort to agree on such markers would accelerate progress towards regulatory acceptance.
That said, we may need to look at intermediate steps. Chronic inflammation (“inflammaging”) is now widely recognised as a major component of age-related risk and decline, and we already have promising biomarker candidates such as suPAR and Omniscope metrics. Perhaps agreeing to treat inflammaging as a targetable risk factor might be more straightforward — at least while large sections of the population and many politicians continue to view aging as an inevitable natural process.
As I believe it is timely to tackle the regulatory barrier, I am bringing together a group of experts to:
Examine existing regulatory and evidentiary frameworks, including those of the FDA, EMA/CHMP (geriatric medicines strategy), and MHRA;
Learn lessons from recent GLP-1 experience and other drug classes that clearly interact with the aging process;
Define an acceptable set of aging biomarkers (epigenetic, inflammaging levels, etc.) and functional endpoints likely to be recognised across agencies;
Outline trial designs for therapies targeting chronic disease prevention, frailty, and healthspan extension, compatible with a new framework for regulatory assessment and approval; and
Build bridges between regulators, HTA bodies, clinicians, and advocacy groups to create a globally aligned, sustainable route to approval and access.
This effort is just getting off the ground.
If you’d like to be involved, contribute ideas, or recommend someone who should be part of the group, please click here to reach out to me directly.
Let’s do all we can to smooth the path for anti-aging therapies that could benefit so many.
