Gilead Withdraws Request for Special Orphan Status on Experimental Coronavirus Treatment

In a statement, Gilead said it had sought the orphan status to expedite approval of the drug, in particular a required pediatric study that, without such a designation, the company said could have taken up to 210 days to complete. But Gilead said that after speaking to regulators, it was confident the application would move quickly.

“Gilead recognizes the urgent public health needs posed by the Covid-19 pandemic,” the drugmaker said. “The company is working to advance the development of remdesivir as quickly as possible and will provide updates as they become available.”

Peter Maybarduk, the director of a program of the social advocacy group Public Citizen that seeks to expand global access to medicines, rejected the company’s argument that a pediatric study would have slowed the process. “We have to know whether a drug may affect children differently than adults,” he said. “Gilead should not have been looking to skip this step in the first place.”

Remdesivir is being studied in several large-scale clinical trials around the world, including in a huge trial announced last week by the World Health Organization. But the results have not been reported yet, and it is still unclear whether the drug works against the coronavirus. It was studied to treat Ebola, but it did not work well enough against that virus.

Last week, President Trump promoted the drug as one of a handful that might work against the coronavirus. Gilead has been inundated with requests for “compassionate use” access to the drug from doctors with dying patients who are desperate to try anything that might help.

This past weekend, Gilead said that the overwhelming demand had created a backlog and that it was switching from approving access on a case-by-case basis to a system in which patients would be approved in large groups. But that new program has not yet gotten underway, leaving some doctors and patients scrambling. A Gilead spokeswoman said on Wednesday that the company’s goal was to have the broader program up and running at some sites in the United States this week, with others to come after that.

Article source: https://www.nytimes.com/2020/03/25/health/gilead-coronavirus-orphan-drug.html