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# Rescind Remdesivir Orphan Designation: Gilead
- URL: https://www.fdaweb.com/rescind-remdesivir-orphan-designation-gilead/
- Published: 2020-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:08:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146414

Gilead Sciences says it has asked FDA to rescind the orphan drug designation it was recently granted for the investigational antiviral remdesivir for treating Covid-19\. A company [statement](https://www.gilead.com/-/media/gilead-corporate/files/pdfs/company-statements/remdesivir-orphan-drug-designation.pdf?la=en&hash=ED14BC7B26E2FEAA2E31E7741A8C9692&ref=fdaweb.com) says Gilead is waiving all benefits, such as seven-year exclusivity, that come with an orphan drug designation. The company had sought and was subsequently granted the designation earlier in March.

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan drug designation,” the statement says. “Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of Covid-19 are being expedited.”