Repurposing – what is it and why it’s important for COVID-19 (Guest blog)
29.04.20
COVID-19 has emerged as a brand new disease with a severe impact on patients, the public and health systems around the world. As a new disease, researchers have only had a few months to learn about the disease and how to treat it but the global impact continues to grow. Developing medicines and vaccines is a process which takes years so researchers are also looking to see if existing medicines can be used to treat patients with COVID-19, a process also known as repurposing.
“Repurposing” is a concept used to describe a new use for an existing medicine, already licenced for another treatment. The new use will usually be supported by some level of clinical data and may or may not be ready to submit to authorities for licensing. In cases where the data is submitted to a competent regulatory authority and is subsequently approved by it to meet the standards for efficacy, safety and quality, the medicine will be granted a licence extension for that use. In all other cases, any new use of the medicine is regarded as “off-label” usage. This means that, although the product is already licensed for one or more other indications, the regulatory authorities have not reviewed and approved the data to ensure it meets standards for efficacy, safety and quality for the new indication.
Repurposing is not a new concept for the pharmaceutical industry. Part of the normal process of developing new medicines includes looking at older medicines that may or may not being used still, and starting development again in the potential search for new uses. Repurposing increases efficiency, and medicines are generally approved sooner (3-12 years)[1].
One of the quickest options for tackling COVID-19 is to try repurpose existing treatments, for example medicines that are already approved for treating other viral infections (such as HIV). This is because the safety profile of these medicines is already established, and a relatively simple clinical trial could demonstrate whether or not such a medicine would be effective against Covid 19. Other such medicines that might possibly be effective and are being tested are selected immuno-modulating treatments, and some anti-malarials.
However the route to take a medicine through testing in a new use and through the regulatory process has not, prior to COVID-19, been straightforward. EFPIA, together with other trade associations, patient groups and regulators from around Europe have been working together with the European Commission on a repurposing pilot project with STAMP[2], due to launch soon.
A key aspect of the pilot project was to find ways to bring together academic researchers, companies, charities and regulators to look at new uses of older medicines. We are now seeing that happen at unprecedented levels in the fight against COVID-19. A key example is the SOLIDARITY[3] trial being organised by the World Health Organisation. This trial is taking existing treatments for multiple sclerosis, HIV, Ebola and malaria to see if any of them work against COVID-19.
Let’s hope that we have positive lessons to be taken from the COVID-19 situation that can be applied across all disease areas.
[2] https://ec.europa.eu/health/documents/pharmaceutical-committee/stamp_en (EU Commission, 2019)
