Reversing course, Gilead asks FDA to rescind remdesivir's Orphan designation

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Two days after receiving Orphan Drug designation for its COVID-19 therapeutic, Gilead has asked FDA to rescind the status and said it would waive “all benefits that accompany the designation.”

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” the company said in a statement.

The designation would have given Gilead Sciences Inc. (NASDAQ:GILD) seven years of exclusivity for the antiviral if approved (see “Gilead Looks to Expand Access to Remdesivir”).

A product can qualify for Orphan Drug designation if it is intended to treat a condition that affects 200,000 or fewer Americans. When FDA granted remdesivir the designation Monday, about 33,000 people had tested positive for the coronavirus in the U.S.; on Wednesday, there were over 54,000 cases, according to CDC.

Gilead said it had initially ask for the designation in early March; one benefit of Orphan Drug status is it waives the requirement to provide a pediatric study plan prior to NDA submission.

Remdesivir is being evaluated in at least five Phase II and III clinical trials to treat COVID-19 (see “NIH, Hubei Trials Could be more Telling than Gilead's”).

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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