Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Gilead Requests Retraction of Orphan Designation for Remdesivir | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Gilead Requests Retraction of Orphan Designation for Remdesivir

Seeks to waive all benefits amid growing concerns the specialty status could impact pricing and availability of competitor products

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

Gilead Sciences has requested the U.S. FDA rescind orphan drug designation for remdesivir, a potential COVID-19 treatment, waiving all benefits associated with the designation.

The request comes amid growing concerns the specialty status could impact pricing and competitor products.

Orphan drug designation is given to investigational compounds intended to treat a rare disease, affecting fewer than 200,000 persons in the U.S., or a condition that has limited treatment options. Orphan drug status comes with certain benefits such as marketing exclusivity and waiver of prescription drug user fees, and certain testing requirements.

Remdesivir is an antiviral drug currently being evaluated in Phase III clinical trials as a potential treatment for severe and moderate manifestations of COVID-19.

Gilead recently suspended compassionate use access of remdesivir to patients with severe coronavirus due to overwhelming demand.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters