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
Everest’s Renal Drug Gets Placed On Fast Track For Approval In Taiwan And Korea
2022-11-28
Walmart To Settle Opioid Lawsuits with $3.1 Billion, U.S. Government Mulls OTC Naloxone
2022-11-15
CDC Warns Of “Tripledemic” Winter Amid Rising Flu And RSV Cases
2022-11-14
LATEST
Rebyota Passes Through FDA To Become First Approved Fecal Microbiota Product
2022-12-05
RemeGen Presented New Data Updates on Telitacicept for SLE and primary Sjogren’s syndrome at ACR Convergence 2022
2022-12-05
EMA Urges Pholcodine’s Removal from European Market Following Safety Study
2022-12-05
Lynk Pharmaceuticals Announces First Patient Dosed in Phase Ⅱ Clinical Study of LNK01003 in Patients with Ulcerative Colitis
2022-12-04
Cure Brain Cancer Foundation Rings Nasdaq Opening Bell, Announces U.S. Expansion
2022-12-02
Focus-X Therapeutics, a Viva Biotech Portfolio Company, Successfully Reached an Acquisition Agreement with Full-Life Technologies
2022-12-02
Pfizer To Invest $1.26 Billion In Irish Plant, Forms New Vant Company Targeting Inflammation
2022-12-02
EVENT
2022-12-10
64TH ASH ANNUAL MEETING & EXPOSITION
New Orleans, USA
2022-12-14
BIOHK2022
Hong Kong, China
2022-12-21
Avatar Medicine Forum
Online
2023-01-07
7th Asia Microbiome Conference
Taipei, Taiwan
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!