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Regulatory Focus™ > News Articles > 2020 > 6 > Revise remdesivir EUA to add registry, say researchers

Revise remdesivir EUA to add registry, say researchers

Posted 25 June 2020 | By Kari Oakes 

Revise remdesivir EUA to add registry, say researchers

The US Food and Drug Administration (FDA) should create a patient registry to track key information about COVID-19 patients treated with remdesivir, according to three Harvard Medical School researchers. The researchers also called for FDA to begin negotiations with Gilead, which markets remdesivir, about pricing for the antiviral drug.
In a Viewpoints article published yesterday in JAMA, Ameet Sarpatwari, PhD, JD, and coauthors noted that FDA’s 1 May emergency use authorization (EUA) for remdesivir to treat hospitalized patients who are severely ill with COVID-19 was based on interim results of a phase 3 placebo-controlled trial that showed shorter median recovery time for patients receiving remdesivir. However, the trial, designed and funded by the National Institute of Allergy and Infectious Diseases (NIAID), did not show a significant increase in survival in the remdesivir group. The authors cited two other placebo-controlled trials that have not shown significant clinical improvement with remdesivir.
Sarpatwari, of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, Boston, and colleagues pointed out that FDA may revise an EUA after issuance, adding that the remdesivir EUA “does not contain terms adequate for monitoring the drug’s use or outcomes.” The EUA does currently require reporting of any adverse events suspected to be medication-related through FDA’s passive surveillance system, which the authors say “has historically been limited by underreporting and incomplete reporting.”
The authors rather call for a registry that would collect patient demographic information, dosing details, and safety outcomes, analogous to those required for risk evaluation and mitigation strategy (REMS) programs. The registry should be maintained by FDA or a third party rather than the manufacturer, said Sarpatwari and coauthors, in order “to avoid past missteps that occurred with REMS programs,” and deidentified data from the registry should be available to the public.
In addition to providing important ongoing safety information about remdesivir’s use for severe COVID-19 patients, issues of access and equity would come to light under the registry scheme. “Historically, racial and ethnic minority populations have been slower to receive innovative treatments, an outcome that could be prevented or, at minimum, identified and remedied through transparent reporting,” said the authors.
Pricing negotiations with Gilead should take multiple factors into account, said the authors, now that the firm has signaled that it will soon start charging for remdesivir after a donation of 940,000 doses. On the one hand, innovation should not be discouraged during this public health emergency, they said: “Remdesivir will not solve the pandemic, but it does appear to have some efficacy in reducing recovery time. This should be reflected in its price, which will serve as a signal to other innovators that their efforts will be fairly rewarded.”
On the other hand, remdesivir’s development has been heavily funded by the US government, they said. It was work done under a US Army contract that plucked remdesivir from Gilead’s library of molecules as a potential Ebola virus treatment; the drug had been developed as potential hepatitis C virus treatment. Further, late-stage studies of remdesivir to treat Ebola were also NIAID-designed and -funded, an unusual arrangement that put more risk on taxpayers as clinical development proceeded. “The trade-off for this off-loading of risk should be affordable access to the product,” wrote Sarpatwari and colleagues. “Such accounting would importantly still permit Gilead to profit from creating value but would be commensurate with its risk-taking,” they added.
In discussing potential bounds of pricing, the authors cited a recent Institute for Clinical and Economic Review (ICER) report estimating that a cost-effective price for 10 days of remdesivir treatment would be about $4,500. The non-profit group also estimated that the minimal price to recoup costs of drug production could be as little as $10. “Gilead has yet to comment on these estimates for what the bounds of a reasonable price could be,” said the authors.
One coauthor reported recieving fees from AstraZeneca and SVB Leerink; she has also served on an ICER advisory committee. The other authors reported no conflicts of interest. The work was funded by Arnold Ventures and the Harvard-MIT Center for Regulatory Science. 


Tags: coronavirus, FDA, US

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