Veklury is the first approved antiviral agent now for extended pediatric use and for those patients who are suffering in all stages of renal disease

Veklury, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, was approved by FDA for the treatment COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5kg) who are hospitalized, or not hospitalized and have mild to moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. By the recently extended approval for pediatric patients weighing 1.5kg to less than 40kg allows the dosage form of Veklury for injection. [1, 2] Veklury for injection is supplied as a 100mg lyophilized powder in a vial that must be reconstituted and diluted prior to intravenous infusion. Earlier we reported on this blog on the approval for pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) [3].

The followers of the Cyclodextrin News blog were informed on the approval for use in patients with all stages of renal disease. [4-6] The concern about eventual kidney toxicity of Veklury treatment in patients with chronic kidney disease arose due to the administration of high amount of excipient, the polyanionic sulfobutylether-beta-cyclodextrin-SODIUM. No new safety signals were observed in the clinical studies.

[1] https://www.empr.com/home/news/pediatric-approval-of-veklury-for-covid-19-treatment-further-expanded/

[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214787s026lbl.pdf

[3] https://cyclodextrinnews.com/2022/04/29/fda-approves-first-covid-19-treatment-for-young-children/

[4] https://cyclodextrinnews.com/2024/02/27/renal-safety-of-sbecd/

[5] 3. https://www.idse.net/FDA-News/Article/07-23/FDA-Expands-Indication-for-Veklury-to-Treat-COVID-19-Patients-With-Renal-Impairment/70867

[6] V. Antle, J.D. Pipkin, L. Rejewsk: SOLUBILIZING & STABILIZING TECHNOLOGY – CAPTISOL® – Part Perseverance & Part Serendipity. Drug Development & Delivery 2023, 7, 32-38. https://drug-dev.com/solubilizing-stabilizing-technology-captisol-part-perseverance-part-serendipity/