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Gilead Drug First to be Approved by FDA for COVID-19 Treatment

CSG Associates in Action

By Leslie Burk, CSG strategic initiatives manager

Following natural disasters and in times of national crisis, America’s private sector steps up to aid the states. We are proud of the herculean efforts of CSG Leadership Circle and Associates, our private sector members, as we together combat COVID-19.

Gilead Sciences, Inc., a CSG Associate, announced on Oct. 22 that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States. The drug is now widely available in hospitals across the country.

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.

In the United States, Veklury is indicated for adults and pediatric patients for the treatment of COVID-19 requiring hospitalization. This approval is based on three randomized controlled trials which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on this data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.

“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.”

Veklury significantly improved time to recovery, by five days in the overall study population and seven days in patients who required oxygen support. Veklury also reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation.

As announced on October 1, Gilead is now meeting real-time demand for Veklury across the states  and anticipates meeting global demand for Veklury even in the event of potential future surges of COVID-19.

Associates in Action articles highlight CSG Associates’ philanthropic efforts and public-private partnerships throughout the states.