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Gilead’s innovative medicine, Veklury® (remdesivir), has been making headlines as the first antiviral treatment for COVID-19 to demonstrate patient improvement in clinical studies — enabling patients to recover more quickly, and freeing up provider time and hospital resources.
Since January, Gilead has taken multiple steps to ramp up production and rapidly build supply of Veklury®, preparing for potential global demand.
In August, the company announced it was seeking full regulatory approval for Veklury® to treat COVID-19, the final milestone needed for the medicine to be used widely with coronavirus patients. That approval was granted in October, making it the first and only FDA-approved treatment for COVID-19 in the United States. Prior to final approval, the FDA had broadened the emergency use authorization for Veklury® to include all hospitalized adult and pediatric patients with COVID-19, reflecting the growing amount of available clinical data for Veklury® and its potential to improve outcomes for patients.
In recent weeks and months, Gilead has moved forward with plans to manufacture and deliver the drug for widespread use. Because Veklury® is delivered intravenously and is complex to manufacture, Gilead is partnering with 40 companies across North America, Europe, and Asia, with a goal of meeting global demand.
The company also announced it would team up with Pfizer to produce Veklury® at Pfizer’s McPherson, Kansas facility. The partnership illustrates the unprecedented scope of industry collaboration to combat COVID-19. Pfizer’s CEO Albert Bourla said it best: “Together, we are more powerful than alone.”
As a result of the decision to make early investments to increase Veklury® manufacturing efforts, Gilead is now meeting real-time demand for Veklury® in the United States and anticipates meeting global demand, even in the event of potential future surges of COVID-19.
An Urgent Mission
Gilead, headquartered in Foster City, California, is a biopharmaceutical company operating in 35 countries that discovers, develops, and commercializes medicines in areas of unmet medical need.
When the news of the novel coronavirus first emerged, Gilead immediately began to investigate the potential of remdesivir, a medicine the company had been studying for years as part of its research in antivirals. From there, Gilead worked at an unprecedented speed to enroll patients in clinical trials and to determine whether the drug was safe and effective against COVID-19.
Collaboration will be key to manufacturing and delivering the drug, but the scope of industry collaboration also extends to research and development. Multiple studies of combination treatments are underway in the hope of improving upon patient outcomes.
The National Institute of Allergy and Infectious Disease is evaluating a combination of Gilead’s remdesivir and Eli Lilly’s anti-inflammatory drug baricitinib. Studies are also underway to determine the benefits of Roche’s rheumatoid arthritis therapy tocilizumab in combination with Gilead’s remdesivir.
Yet recently, some actors in the United States are threatening the ability of innovative companies to work together to invest in the science needed to combat COVID-19. Proposals to impose artificial price controls or override patent protection will hinder the research and development into life-saving treatments and cures at a time when they are desperately needed.
Now, more than ever, innovators need to keep their eyes on the ball to deliver solutions to COVID-19, but they can’t do it alone. There are currently 656 clinical trials for COVID-19 therapeutics and vaccines taking place across all 50 states. Explore the U.S. Chamber’s interactive map to see the COVID-19 research going on in your community.
Each week we’re spotlighting companies on the front-line search for effective treatments and vaccines to combat COVID-19. Visit the Global Innovation Policy Center’s Discover & Deliver page to learn more.