The use of remdesivir outside of clinical trials during the COVID-19 pandemic.

Authors :: Halimi V
Daci A
Ridova N
Panovska-Stavridis I
Stevanovic M
Filipce V
Dimovski A
Grozdanova A
Source :: Journal of pharmaceutical policy and practice [J Pharm Policy Pract] 2020 Sep 21; Vol. 13, pp. 61. Date of Electronic Publication: 2020 Sep 21 (Print Publication: 2020).
Publication Year :: 2020
Abstract: With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols.<br />Competing Interests: Competing interestsVesa Halimi, Armond Daci, Nevenka Ridova, Irina Panovska-Stavridis, Milena Stevanovic, Venko Filipce, Aleksandar Dimovski, and Aleksandra Grozdanova declare that no competing interests exist.<br /> (© The Author(s) 2020.)