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The DSRU said global collaboration would be needed to successfully accelerate the necessary safety and efficacy assessments for repurposed drugs for use in COVID-19 patients.
The UK Drug Safety Research Unit (DSRU) has published a review of the benefits and challenges of reusing existing drugs for COVID-19. The review concluded that repurposed drugs still need rigorous testing to establish that they are safe and effective, and the DSRU is now urging institutions around the world to work together to reduce duplicates and accelerate development.
According to the review, the only reused drug currently licensed for use in patients with COVID-19 is remdesivir, an antiviral originally developed for the treatment of Ebola. It is approved in Japan, has a conditional marketing authorization from the European Commission, and is accessible under emergency use schemes in the UK and US. The DSRU said it expects further repurposed drugs to follow.
Professor Saad Shakir, Director of the DSRU, said: “Reusing existing medicines can save time and money as we already have information on their safety since they have been used to treat other diseases.
“However, even repurposed drugs still need to undergo rigorous testing to ensure they are effective in treating COVID-19 and are safe for patients with COVID-19. As for their effectiveness, repurposed drugs that may work. very differently for COVID-19 they may require a lot more research before we know they are safe and effective.
“Regulators are speeding up the approval process, which is needed in a global pandemic. But it does mean there will likely be more gaps in our knowledge about new COVID-19 treatments as the general public starts using them. Continuing “post-authorization” monitoring and research will be even more essential to ensure the recording of rare and long-latency side effects. “
The review provides an overview of existing drugs currently being tested for the treatment of COVID-19, including 50 that could inhibit one or more stages of the coronavirus life cycle and many others that could potentially counter the effects of SARS infection. -CoV-2, with a particular focus on the overactive immune response that can cause the most serious complications (abnormal clotting of spots and acute respiratory distress syndrome [ARDS]).
In the review, they highlight the challenges related to correctly interpreting existing pre-clinical and clinical evidence and how to best generate new evidence, as well as outlining the regulatory processes involved in drug repurposing and what drug trials may be needed to support the use of repurposed drugs.
The paper concludes that researchers, pharmaceutical companies and regulators around the world will need to work together to plan studies strategically and avoid duplication to ensure that drugs can be successfully evaluated and compared.
The review was published with colleagues from the University of Messina, Italy, in Frontiers of pharmacology.
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