Gilead won a valuable FDA voucher with its Veklury approval, but patient advocates are urging the company to give it up: report

remdesivir
Gilead pulled in $873 million in Veklury sales during the third quarter.(Gilead Sciences)

Gilead Sciences has the most successful COVID-19 drug so far in Veklury, an antiviral also known as remdesivir that was originally developed through research programs into hepatitis C and respiratory syncytial virus. While there’s an ongoing debate about the med’s efficacy against the novel coronavirus, the drugmaker is already reeling in big sales in the indication—and has also gained an added benefit it doesn't deserve, a patient advocacy group argues.

In addition to sizable Veklury revenues, Gilead scored an FDA priority review voucher with its approval based on success developing a medicine against a “material threat” to people in the U.S. The voucher, which can be sold or used to accelerate a drug review at the agency, represents an “entirely unnecessary and inappropriate incentive," Public Citizen's Access to Medicines director Peter Maybarduk wrote in a letter to Gilead's CEO Dan O'Day posted by Stat.

Public Citizen's Maybarduk called on Gilead to “relinquish” the voucher, arguing that taxpayers have contributed more than $70 million toward Veklury’s development. Plus, Gilead is already benefiting from Veklury sales, he argued. In the third quarter, the drug raked in $873 million, and analysts figure the medicine is on track to post another $650 million to $950 million during the fourth quarter.  

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For its part, Gilead says it invented the drug after "more than a decade of our research.” The work started in 2009 under programs for hep C and RSV, and over the years, researchers have tested the antiviral against Ebola, SARS, Marburg, MERS and COVID-19. The company has acknowledged partnerships with academic institutions and U.S. agencies.

Over three decades, Gilead says (PDF) it has spent billions on antiviral R&D, and that the work has resulted in an “expansive library of compounds” that can be “accessed and tested against new viruses as they emerge.” The company has also spent considerably on its manufacturing scale-up to be able to supply the medicines, execs have said.

Gilead's drug costs $520 per vial, or $3,120 for a five-day course.

FDA priority review vouchers have varied wildly in value over the years, with Regeneron buying one for $67.5 million in 2014 and AbbVie buying one for $350 million the very next year.  

A Gilead spokesperson wrote via email that while the voucher is “transferable,” the company doesn’t plan to sell it “given the many investigational compounds in our pipeline that we believe have the potential to transform the treatment of serious diseases for individual patients and to advance global health.”

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Public Citizen’s letter comes amid a debate over Veklury's benefits in treating COVID-19. The FDA recently approved the drug based on three studies that showed the medicine was associated with improvements “across multiple outcome assessments” compared with placebo in hospitalized patients. Separately, a large World Health Organization study found the drug provided “little or no effect” in hospitalized patients in terms of recovery time, requirement for ventilators and death rate. Gilead challenged the WHO study design and urged people to not make judgments based on the findings.

Still, with the data so far, and with a lack of other available treatments, Gilead’s medicine has become the standard of care for hospitalized patients. Veklury is the only drug so far to win a full FDA approval in COVID-19, while Regeneron and Eli Lilly have submitted their experimental antibody treatments for potential emergency use authorizations.