Working to Supply Remdesivir for COVID-19
Since the moment the novel coronavirus that causes COVID-19 was identified, Gilead has mobilized every area of our organization to respond to the global health emergency. We are harnessing our decades of expertise in antiviral research and development, including more than 10 years of work on remdesivir specifically, to advance a potential treatment for COVID-19 and help meet the ever-growing patient needs, should the medicine receive emergency authorizations or regulatory approvals around the world.
Learn more about the development of remdesivir.
Since January, Gilead has invested significant capital to establish a supply chain capable of large-scale production of remdesivir.
The production of remdesivir is a long, linear chemical synthesis process that must be completed sequentially and includes several specialized chemistry steps and novel substances with limited global availability. The process is both resource- and time-intensive, with some individual manufacturing steps taking weeks to complete. Because remdesivir is administered intravenously, production also requires sterile drug product manufacturing capabilities, which limits the number of organizations capable of manufacturing the medicine. This complex process impacts the ability to rapidly produce large quantities of drug supply in an emergency situation like the COVID-19 pandemic. In light of these realities, Gilead worked early on, before any clinical trials had started, to procure a steady flow of long-lead-time raw materials that will accelerate large-scale production of remdesivir by our current and future partners once these materials become available in significant quantities.
We have also worked to shorten the manufacturing timeline through process improvements. The typical timeline for manufacturing a drug like remdesivir at scale is nine to 12 months; we have reduced that period to six to eight months. We continue to work on optimizing the chemical synthesis processes to further accelerate product deliveries and volumes.
Current and Projected Supply
As of January 2020, we were not actively manufacturing remdesivir. The manufacturing supply chain was scaled to periodically make small amounts of product for a compound in early development. We had inventory of finished product to treat just 5,000 patients.
Since then, we have proactively and rapidly scaled our supply chain. As of late March, using the active ingredient we already had in our inventory, we have increased our supply. We have worked over the past several months to improve processes, shorten timelines and increase volumes as we work to bring remdesivir to patients as soon as possible. Our goal is to produce a total of:
- More than 190,000 treatment courses by the end of June 2020
- More than 2 million treatment courses by December 2020
- Several million treatment courses in 2021, if required
Capacity Expansion through External Manufacturing
We have supplemented our internal manufacturing with significant additional capacity from multiple manufacturing partners in North America, Europe and Asia. Through these efforts, we believe we have created a manufacturing network capable of producing large volumes of remdesivir at the fastest pace feasible.
Efforts to Further Increase Supply
While cases of COVID-19 continue to increase, only a portion of patients experience severe symptoms that may make them appropriate candidates for treatment with remdesivir. Patients currently receiving remdesivir through clinical trials or expanded access are hospitalized and have moderate to severe manifestations of COVID-19, such as early respiratory failure. According to the World Health Organization, approximately 14% of patients with COVID-19 will experience severe manifestations of the disease that require hospitalization and supplemental oxygen, and 5% will require treatment in intensive care units. The potential benefits and risks of treatment with remdesivir for COVID-19 are not yet fully known.
We have also received clearance from the U.S. Food and Drug Administration to move forward with an investigational inhaled version of remdesivir. We will begin by studying the drug in healthy volunteers, with the goal of starting studies in patients with COVID-19 by August. An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease.
We are doing everything we can to accelerate manufacturing timelines and quantities of remdesivir to meet the growing demand for emergency use of the medicine from around the world and for clinical trials to determine whether remdesivir is safe and effective for the treatment of COVID-19. In addition to multiple ongoing clinical studies actively enrolling patients, we are implementing expanded access programs as quickly as possible to help the most critically ill patients around the world with our limited supply.
Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir, a nucleotide analog, for the treatment of COVID-19. In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir have not been established.
Remdesivir has not been approved by the U.S. FDA for any use. In the U.S., the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorization in the U.S., please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available here.
Updated: June 24, 2020