The FDA recently lifted an import ban it had imposed in 2015 on India’s Ipca Laboratories due to quality issues and non-adherence to good manufacturing practice (GMP), in an effort to sufficiently supply the US with two malaria drugs, chloroquine and hydroxychloroquine, that could potentially be used for the treatment of the coronavirus (COVID-19).

Elena Tzima, GlobalData Oncology & Hematology Analyst, offers her view on the resurgence of interest in chloroquine and hydroxychloroquine to combat COVID-19;

“Although there is currently no robust scientific data from clinical trials for the efficacy of chloroquine and hydroxychloroquine in the treatment of COVID-19, both of these drugs have shown in vitro activity against the SARS-Cov and SARS-Cov-2 viruses, the latter being the COVID-19 virus, and other coronaviruses, thus supporting the idea of using them against COVID-19. A series of clinical trials with hospitalised COVID-19 patients across China have been conducted on the use of these drugs in their treatment.

“The results from these trials demonstrated an effect of chloroquine in the inhibition of the exacerbation of disease-associated pneumonia and an effect in the improvement of patient lung imaging results and in shortening the disease course to recovery.

“Based on these findings, the drug was recommended by the National Health Commission of the People’s Republic of China to be included in new guidelines for the prevention, diagnosis and treatment of COVID-19-associated pneumonia.

“Although China authorised the use of chloroquine based on their findings in clinical studies, it is unlikely that the US and Europe will do the same, with the exception of compassionate use, without seeing more robust scientific evidence first to support this intervention.

“There are currently three new randomised, controlled clinical trials at various stages testing hydroxychloroquine in the treatment of COVID-19, and three new randomized, open label clinical trials testing chloroquine for the treatment of COVID-19 globally as well as a global mega-trial, named SOLIDARITY, launched by WHO to investigate the four most promising drugs against COVID-19, including both chloroquine and hydroxychloroquine.

“However, until proven efficacious and safe for the treatment of this disease through clinical trials, the FDA is warning against the use of non-approved drugs for COVID-19. The use of chloroquine and hydroxychloroquine in this setting remains anecdotal and should be considered carefully as, although so far well-tolerated in studies with COVID-19 patients, these drugs do come with side-effects ranging from mild side effects such as skin rush and nausea to more serious cardiomyopathy and retinopathy.”

ENDS

Notes to Editors

There are currently three new randomised, controlled clinical trials at various stages testing hydroxychloroquine in the treatment of COVID-19, and three new randomized, open label clinical trials testing chloroquine for the treatment of COVID-19 globally as well as a global mega-trial, named SOLIDARITY, launched by WHO to investigate the four most promising drugs against COVID-19, including both chloroquine and hydroxychloroquine. So these two drugs have definitely drawn some attention.

Although most of the clinical trials are conducted by academia, big pharma companies also have their eyes on them with Sanofi being the collaborator on one of these trials (National Institute of Respiratory Diseases Mexico, NCT04315896). Novartis, Bayer, Mylan and Teva have also promised to supply chloroquine and hydroxychloroquine to support the medical response to this pandemic.