Gilead Requests FDA to Rescind Remdesivir’s Orphan Drug Designation

By Rajaneesh Karimpurath Gopinath, Ph.D.

In a total U-turn, Gilead Sciences has now requested the U.S. Food and Drug Administration (USFDA) to rescind the orphan drug designation (ODD) granted to remdesivir which is currently under several clinical trials around the world for the treatment of COVID-19. The company is willing to waive all benefits that accompany the designation.

Remdesivir an investigational antiviral, that is already being administered to severely affected patients on a compassionate use basis. However, an ‘overwhelming demand’ had forced the company to temporarily suspend access. Following an expedited review, yesterday, the USFDA had granted ODD status to remdesivir after Gilead filed for it in early March. Besides accelerating the review process by several days, this new status also gave Gilead, tax incentives as well as seven years of market exclusivity for drug production.

The ODD status surprised several analysts as it is was usually given to drugs treating rare diseases that affect fewer than 200,000 patients in the US. The COVID-19 pandemic is anything but rare and therefore invited criticisms from some quarters who felt that the new status could be exploited for financial benefits. One of the major voices against the decision was that of Senator Bernie Sanders of Vermont.

“It is truly outrageous that after taxpayers put tens of millions of dollars into developing remdesivir, Trump’s FDA is exploiting a law reserved for rare diseases to privatize a drug to treat a pandemic virus. The Trump Administration must rescind this corporate giveaway to Gilead and make any treatment and vaccine free for everybody” he said in an official statement. “Now is not the time for profiteering in the pharmaceutical industry. Now is the time to bring our scientists together to develop and produce the best treatment for the coronavirus as quickly as possible” he added.

Gilead’s turnaround has now squashed any such speculations. In an official statement, the company said that the recent engagement with regulatory agencies has been expedited. Therefore, it is confident that it can continue to maintain that pace in seeking regulatory review of remdesivir, without the orphan drug designation.

Related Article: Gilead’s Remdesivir Wins FDA’s Orphan Drug Designation for COVID-19 Treatment

References

1. https://www.gilead.com/-/media/gilead-corporate/files/pdfs/company-statements/remdesivir-orphan-drug-designation.pdf?la=en&hash=ED14BC7B26E2FEAA2E31E7741A8C9692
2. https://www.sanders.senate.gov/newsroom/press-releases/sanders-calls-on-trump-to-rescind-pharma-giveaway-of-potential-coronavirus-treatment

Author

Rajaneesh K. Gopinath