Manufacturing Network Expanded for Producing Remdesivir

Gilead Sciences has expanded its capabilities for manufacturing remdesivir (Veklury) in preparation for potentially greater global demand.¹ In recent studies, the investigational drug has been shown to offer potential benefit to hospitalized patients with coronavirus disease 2019 (COVID-19).²

Remdesivir is not approved by the FDA for any use; however, the FDA has granted Emergency Use Authorization to the drug for the treatment of hospitalized patients with severe COVID-19.^1,3

Research has suggested that remdesivir can reduce COVID-19 deaths by as much as 30%. Additionally, a recent study found the drug to shorten ICU stays, which could allow hospitals with limited capacity the ability to treat more patients.²

Gilead is investing more than $1 billion this year to expand manufacturing capability for remdesivir.³ Since January 2020, the manufacturer has grown the supply of the drug 50-fold,² having taken multiple steps to increase production.^1,3

Recent efforts have shortened the lengthy manufacturing timeline to 6 months through process improvements. Additionally, Gilead has grown its network of internal manufacturing sites and external organizations, which include partnerships with industry peers. According to Gilead, the manufacturing network for producing remdesivir has increased to more than 40 companies in North America, Europe, and Asia.¹

Further increasing production capability for remdesivir, Gilead has entered into voluntary licensing agreements with 9 manufacturers of generic drugs. These agreements are expected to expand the drug’s supply to 127 countries that represent many low-income and lower-middle income populations. According to Gilead, it has completed technology transfers with these 9 companies, and they already are starting the manufacturing process.¹

Current NIH guidelines recommend that remdesivir be prioritized for hospitalized patients requiring supplemental oxygen. According to Gilead, the recommendation represents a very small percentage of patients diagnosed with COVID-19, and many patients with the virus will recover without ever needing this drug. Currently, most eligible patients hospitalized in the United States are able to get remdesivir.³

REFERENCES

• Gilead Sciences Update on Veklury® (Remdesivir) Manufacturing Network [news release]. Foster City, CA; August 6, 2020: Gilead Sciences website. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-update-on-veklury-remdesivir-manufacturing-network Accessed August 6, 2020.
• Karlovitch S. Remdesivir Can Have ‘Double Impact’ if Used in Coronavirus Hot Spots. Pharmacy Times website. https://www.pharmacytimes.com/news/remdesivir-can-have-double-impact-if-used-in-coronavirus-hot-spots Published July 9, 2020. Accessed August 6, 2020.
• Gilead Sciences Statement on State Attorneys General Letter on Remdesivir [statement]. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-state-attorneys-general-letter-on-remdesivir Published August 5, 2020. Accessed August 6, 2020.