Leading Scientists Call for Large-Scale Manufacturing of Remdesivir

Remdesivir should be part of the “first wave” of efforts to expedite COVID-19 treatments and vaccines, the members of Scientists to Stop COVID-19 said in a plan submitted to the White House.

The group of more than a dozen prominent scientists is urging the U.S. government to push for the use of Gilead’s remdesivir on a large scale, and for extensive manufacturing by companies in addition to Gilead.

The scientists also believe that the current dose of remdesivir being tested may be too low. The drug is being tested in multiple trials at an initial 200 mg dose followed by 100 mg for five to 10 days, but the group said that the dosage may have been picked because of supply concerns.

“We believe this dose may be too low and treatment should be administered earlier in symptomatic patients,” they said.

They also called for the FDA to work with Gilead to obtain clinical trial results as the company receives them instead of waiting for an NDA to be filed. That could significantly speed up the process and pave the way for provisional approval if results are positive, the group said.

The members of Scientists to Stop COVID-19 include Nobel laureate Michael Rosbash, a professor of biology at Brandeis University; Edward Scolnick, former head of research and development at Merck; and David Liu, professor of chemistry and chemical biology at Harvard University.

Read the plan here: www.fdanews.com/04-28-20-ScientistsStopCOVID19.pdf. — James Miessler