Aging as a Disease

Is aging a disease? Many scientists think so. This question became relevant a decade ago with the publication of the now famous paper ‘The Hallmarks of Aging’. In this paper the molecular and cellular causes of aging are defined. In the original paper (an update was published 2022) nine so called ‘hallmarks’ are listed. Among them are e.g. stem cell exhaustion and senescent cells.

As soon as The Hallmarks of Aging where published it became obvious that it was possible target them in drug development. Exactly that happened, and there are now over 40 ongoing clinical trails. Over $30 B has since been invested in this new nisch of the biotech industry, and there are over 150 longevity companies around the world.

This is really happening.

This is a spectacular and wonderful development. These new longevity or ‘anti-aging’ therapeutics are not going to make us immortal, but they will extend the healthy part of life significantly (sometimes called ‘healthspan’). Imagine being able to travel the world or running a marathon at the age of 90. Not to mention having the risk of age-related disease reduced drastically. Living health longer.

However, there is a problem: these new longevity drugs are not being developed as fast as they could be.

This is because aging is not classified as a disease. Why? Every new drug must be approved by regulatory authorities, e.g. the FDA in the US and EMA in the EU. These agencies require that an indication is specified. In order words, you need to tell them which disease your drug is to be used for. This is pretty obvious and reasonable. What’s not reasonable is this: you can only choose a disease listed in ICD (International Classification of Diseases), of which aging is not a part.

This means that it is not possible to directly develop a drug that targets the fundamental, molecular damage caused by aging. Not good.

The workaround most common today is called ‘label expansion’. It’s very simpel: first target a age-related disease, e.g. type 2 diabetes, and get it approved by regulators. Then, perform additional studies designed to prove efficiency for additional age-related diseases. You now have one drug that can be used for two or more diseases.

Label expansion is not an optimal way of doing this. What is there’s a drug that has universal rejuvenating effect on the whole body, but no effect on a specific age-related disease? This type of drug is not possible to develop with the current regulatory framework.

This brings us to the obvious solution: classifying aging itself as a disease.

There has been some changes in the right direction. The 11th edition of ICD included two ‘extension’ codes associated to aging: XT9T and MG2A. They are not ‘real’ disease codes, but used rather like an adjective attached to a core disease code to make it more precise. Thus, the problem is still not solved.

This is something that really should be done. It costs nothing and would accelerate drug development within the longevity industry significantly. Let’s do it!