Posted by Michael Wonder on 26 Mar 2020
Gilead declines 'rare disease' status for experimental coronavirus drug
25 March 2020 - In a surprising turnabout, drugmaker Gilead Sciences asked the FDA on Wednesday to rescind orphan status for remdesivir, the company's experimental coronavirus treatment.
The agency granted this status to remdesivir on Monday, prompting a backlash from public health and consumer advocates.
Orphan drug designation is intended to spur development of drugs for rare diseases by bestowing drugmakers with tax breaks, FDA fee waivers and seven years without generic competitors.
