GENE ONLINE|News &
Opinion
Blog

2020-03-25| COVID-19

Gilead Requests FDA to Rescind Remdesivir’s Orphan Drug Designation

by Rajaneesh K. Gopinath
Share To

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

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
WHO Raises Alarm: Bird Flu Threat to Humans an ‘Enormous Concern’
2024-04-19
R&D
Breakthrough Screening Platform to Assess SARS-CoV-2 Mutations and Potential Treatments
2024-04-16
FDA Requests for a $7.2 Billion Budget in FY 2025 for Critical Health Initiatives
2024-03-12
LATEST
Earth Day Awareness: Hospitals Embrace Sustainability Efforts
2024-04-22
WHO Raises Alarm: Bird Flu Threat to Humans an ‘Enormous Concern’
2024-04-19
The Legal Battlefield of Weight-Loss Drugs: Eli Lilly and Novo Nordisk on the Defensive
2024-04-18
Pharmacogenomics in Asia-Pacific: Nalagenetics CEO Levana Sani Offers Insights and Strategies
2024-04-17
Rice University Engineers Develop Miniature Brain Stimulator for Safer and Less-invasive Neuromodulation
2024-04-17
Breakthrough Screening Platform to Assess SARS-CoV-2 Mutations and Potential Treatments
2024-04-16
Join Us for the SABPA OC/LA 16th Annual Biomedical Forum!
2024-04-16
EVENT
2024-04-27
2024 Biomedical Final Pitch Competition
Room DA1620, Dana Building, Dana-Farber Cancer Institute, 99 Jimmy Fund Way, Boston, MA 02115
Scroll to Top