Correct FDA Decision: No Orphan Drug Designation For Remdesivir -- Promising Experimental COVID-19 Therapeutic

After facing intense backlash, in part because taxpayer funds helped discover and develop Remdesivir as a potential therapy for Ebola, originally — and in part because (if the therapy works for COVID-19, as early small trials suggest), it won’t be an “orphan” drug — at all. . . Gilead, likely at FDA’s gentle prodding, withdrew its request to designate the candidate for preferential longer term monopoly status in the US. In this way, no pediatric (think delaying) study will be required. So that too is a. . . benefit.

A bit then, from last week’s news — from my buddie Ed Silvermn, at STAT+ -- but do go read it all:

. . . .The orphan designation would have allowed Gilead to block lower-cost generic version of a vital drug for years, assuming the FDA ultimately approves the medicine, known as remdesivir, for treating the novel coronavirus. Several clinical trials are under way to test the medicine and some results are due shortly, although hopes are already high remdesivir will prove effective. Orphan status also provides tax credits.

For this reason, the Trump administration, whose coronavirus task force includes former Gilead executive Joseph Grogan, was criticized for considering Covid-19 to be a rare disease. The company was also pilloried for seeking the designation. And in its statement, Gilead acknowledged seeking orphan status in early March, suggesting the company was well aware that Covid-19 would not be contained. . . .

In its statement, the drug maker noted that it is waiving all benefits that accompany the orphan designation and “recognizes the urgent public health needs posed by the Covid-19 pandemic. … Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir … and is working to advance the development of remdesivir as quickly as possible. . . .”

Now you know. Out, to. . . nowhere [April Fools'!] -- as safety precribes. . . staying ensconced, in the castle. So we. . . shall. There may be some Shkreli news later today. . . Grin. Across at least five. . . Aprils then. . . .

नमस्ते