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Analysis

Gilead Backtracks on Orphan Drug Designation for Remdesivir

By John Commins  
   March 25, 2020

NIH is testing the antiviral drug's safety and efficacy against COVID-19.

Gilead Sciences, Inc. has asked the federal government to rescind orphan drug designation for remdesivir, an antiviral drug that could be used to fight COVID-19.

"Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic," the Foster City, California-based drug maker said.

"Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation."

Orphan drug designation is granted by the FDA for rare diseases that affect fewer than 200,000 people nationwide.

Remdesivir was originally designed by Gilead to treat Ebola and Marburg viruses.

The drug maker said Wednesday it "is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation." 

Gilead's about-face on the orphan drug status comes as pressure was mounting on the drug maker to rescind the designation, which would have given Gilead a seven-year marketing monopoly.

A group of 50 public advocacy groups rapped Gilead for rushing to get the orphan designation earlier this month while there were fewer than 200,000 known COVID-19 cases in the United States.

"This is an unconscionable abuse of a program designed to incentivize research and development of treatments for rare diseases,” the advocates said in a letter sent Wednesday to Gilead CEO Daniel O'Day.

"COVID-19 is anything but a rare disease. Calling COVID-19 a rare disease mocks people's suffering and exploits a loophole in the law to profiteer off a deadly pandemic."

"Making the claim to special orphan status even more outrageous is the fact that the public already has largely paid for remdesivir's development through at least $60 million in grants and innumerable contributions from federal scientists. America, and the world, has the right to expect better from Gilead," the letter said.

The National Institutes of Health announced Wednesday that it would begin testing remdesivir to determine if it could be used safely and effectively to treat the coronavirus.

“Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic.”

John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.

Photo credit: Soni's / Shutterstock


KEY TAKEAWAYS

Gilead received orphan drug status for remdesivir from the FDA earlier this month. The antiviral was originally designed to treat Ebola and Marburg viruses.

Fifty public advocacy groups had rapped Gilead for rushing to get the orphan status while there were fewer than 200,000 known COVID-19 cases in the United States.


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