Darnitsa’s Stand on Hydroxychloroquine

Darnitsa’s scientists closely monitor authoritative medical research and take into account the world scientific thought, since patient safety and scientific expediency are the unconditional priority for the company. Therefore, the company suspended the project for manufacturing hydroxychloroquine for the treatment of COVID-19.

As of May 26, 201 trials on the use of hydroxychloroquine for treatment of COVID-19 in single-drug therapy or in combination/comparison with other products were registered on ClinicalTrial.gov, and 5 clinical trials have been completed.

Recently, materials from clinical trials have been published that have not confirmed the benefits of the use of the experimental drug hydroxychloroquine in patients with COVID-19. These are, in particular, the following publications:

1. Mehra M., Desai S., Ruschitzka F., Patel A. Hudroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.  Lancet, 2020.
2. Tang W., Cao Z., Han M., et al. Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial. BMJ, 2020.
3. Mahevas M., Tran V-T., Roumier M., et al . Clinical efficacy of hydroxychloroquine in patients with Covid-19 pneumonia who require oxygen: observational comparative study using routine care data. BMJ, 2020.
4. Geleris J., Sun Y., Platt J., et al. Observational study of hydroxychloroquine in hospitalized patients with Covid-19. N Engl. J Med., 2020.
5. Magagnoli J., Narendran S., Pereira F., et al. Outcomes of hydroxychloroquine usage in United States veterans hospitalized with covid-19. medRxiv [Preprint], 2020.

Taking into account those publications, the WHO suspended the treatment of patients with coronavirus infection SARS-CoV-2019 with hydroxychloroquine within the framework of the international clinical trial SOLIDARITY (WHO Director-General's opening remarks at the media briefing on COVID-19 - 25 May 2020. https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---25-may-2020)

Therewith, a number of trials on the use of hydroxychloroquine for treatment of COVID-19 continue.

Darnitsa’s scientists closely monitor authoritative medical research and take into account the world scientific thought, since patient safety and scientific expediency are the unconditional priority for the company. Therefore, the company suspended the project for manufacturing hydroxychloroquine for the treatment of COVID-19.

As a reminder, Darnitsa launched the project of preparing for the manufacturing of drugs containing hydroxychloroquine in March 2020, when Chinese treatment protocols and publications in authoritative sources on the efficiency of the drug for treatment of COVID-19 appeared, namely:

1. Liu J., Cao R., Xu M., Wang X., Zhang H., Hu H., Li Y., Hu Zh., Zhong W., Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2019 infection in vitro. Nature, 2020.
2. Gautret P., Lagier J.C., Parola P. et al. Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study.  Travel Med. Infect. Dis., 2020.
3. Million M., Lagier J.C., Gautret P. et al. Early treatment of COVID-19 patients with hydroxychloroquine and azithromycin: a retrospective analysis of 1061 cases in Marseille, France. Travel Med. Infect. Dis., 2020.

These data gave the grounds to include hydroxychloroquine in the protocols of experimental treatment of COVID-19 in many countries of the world, including Ukraine, the United States and European countries.

At the same time, Darnitsa received numerous requests from Ukrainian physicians and patients to provide the opportunity to use the drug for the treatment of the coronavirus infection, as this therapy was considered by the medical community as potentially effective and affordable. Based on the scientific data and the appeal of the medical community, Darnitsa launched the project of preparing for the manufacturing of drugs with hydroxychloroquine exclusively for the needs of medical institutions in the treatment of COVID-19. Therewith, no open sale of the drug was envisaged.

Currently, the project for the manufacturing of hydroxychloroquine for the treatment of COVID-19 is suspended. However, if necessary, Darnitsa is ready to manufacture this drug for patients with rheumatoid arthritis and systemic lupus erythematosus.

Darnitsa’s scientists will continue to monitor international research to find effective and safe drugs to combat the SARS-CoV-2 virus and will consider the manufacturing of prospective drugs.