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

By Ruchi Jhonsa, Ph.D.

While the clinical trials of this promising drug against SARS-CoV-2 are still on, the FDA has provided a significant advantage to Gilead’s remdesivir today. In an announcement made this evening by the U.S. Food and Drug Administration, the agency has granted orphan drug designation to this promising experimental antiviral, a drug touted by the Trump government for COVID-19 treatment. This designation will grant Gilead Sciences, tax incentives as well as seven years of market exclusivity for drug production.

Remdesivir was already provided to patients with a severe infection on a compassionate use basis but ‘overwhelming demand’ in the past weeks forced the company to temporarily suspend drug access. This was after the news circulated about the recovery of the first coronavirus patient who happened to be under remdesivir treatment. Solid evidence from clinical trials in the coming months will tell us whether remdesivir could actually live up to its hype.

References

1. https://www.reuters.com/article/us-health-coronavirus-gilead-sciences/gileads-potential-coronavirus-treatment-gets-fdas-orphan-drug-label-idUSKBN21A3PR
2. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=739020
3. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-access-to-remdesivir-outside-of-clinical-trials

Related posts:

Gilead Requests FDA to Rescind Remdesivir’s Orphan Drug Designation First to the Finish Line! Remdesivir Becomes the First and Only FDA Approved Drug to Treat COVID-19 COVID-19 Victims on Remdesivir Treatment Hopeful after First US Patient Recovers Potential Repurposed Drugs Currently in Evaluation for COVID-19

Author

Ruchi Jhonsa