Remdesivir: First Approval

The antiviral agent remdesivir (Veklury®; Gilead Sciences), nucleotide analogue prodrug, has broad-spectrum activity against viruses from several families. Having demonstrated potent antiviral activity against coronaviruses in preclinical studies, remdesivir emerged as a candidate drug for the treatment of the novel coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, during the current global pandemic. Phase III evaluation of remdesivir in the treatment of COVID-19 commenced in early 2020 and has thus far yielded promising results. In late May 2020, Taiwan conditionally approved the use of remdesivir in patients with severe COVID-19. This was followed by a rapid succession of conditional approvals in various countries/regions including the EU and Canada. Preceding these conditional approvals, an emergency use authorization for remdesivir had been granted in the USA (on 1 May 2020) and a special approval for emergency use was granted in Japan (on 7 May 2020). This article summarizes the milestones in the development of remdesivir leading to its first conditional approval for the treatment of COVID-19.

Download the full publication here: lamb2020_article_remdesivirfirstapproval.pdf

or continue reading here: Lamb, Y.N. Remdesivir: First Approval. Drugs (2020). https://doi.org/10.1007/s40265-020-01378-w

Captisol – a uniquely modified cyclodextrin in antiviral drugs

In December 2015, Gilead Sciences and Ligand Pharmaceuticals entered into a supply agreement. Under its terms, Ligand Pharmaceuticals would supply Gilead with a uniquely modified cyclodextrin (Captisol®), the chemical structure of which was rationally designed to optimize the solubility and stability of drugs including remdesivir, for use in a Captisol-enabled program directed against Ebola virus disease (in addition to other programs, if expansions to the agreement were agreed by the companies). In turn, Ligand would receive an upfront Drug Master File reference fee, as well as commercial revenue from the shipment of Captisol to Gilead. As of April 2020, Ligand is supplying Captisol to Gilead for use in clinical trials evaluating remdesivir in the treatment of COVID-19.