Is There A Coronavirus Treatment? Drugmaker Asks FDA Drop Orphan Drug Designation Of Remdesivir

Bowing to critics, Gilead Sciences on Wednesday asked U.S. regulators not to label its COVID-19 treatment candidate an orphan drug, which would have given the company significant tax incentives and a virtual monopoly for years.

The U.S. Food and Drug Administration gave Gilead’s remdesivir, which originally was developed to treat Ebola, orphan status earlier this week. The drug is currently undergoing clinical trials to determine whether it is effective and some of the production has been reserved for compassionate use.

Sen. Patty Murray, D-Wash., said the FDA designation was misguided.

Orphan drug status is generally reserved for pharmaceuticals treating diseases affecting 200,000 people or fewer. In a matter of weeks, more than 61,000 Americans have tested positive for the coronavirus. Globally, more than 451,355 have been infected and more than 20,550 have died, including some 800 Americans.

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without orphan drug designation,” the company said. It initially had sought the status in early March. The company said at the time only a few Americans were known to be infected despite the disease’s rapid spread elsewhere in the world.

Remdesivir is among more than 100 drugs and vaccines being tested against the virus, which has become a top priority for pharmaceutical firms. Several of the drugs are believed to have potential including hydroxychloroquine, a generic drug used to treat malaria and some arthritic conditions.

Also being tested are Kevzara, which is made by Regeneron and Sanofi, and favipiravir, which is made by Japanese and Chinese companies. AbbVie said Monday it would drop its patents on its combination drug HIV treatment Kaletra in anticipation it would prove effective against coronavirus. Drugs that treat cancer, Parkinson’s disease and high blood pressure also are being examined.

Two vaccines are being evaluated: mRNA-1273 by Moderna already is being tested, and INO-4800 by Inovio is due to be given to 30 U.S. patients next month.

Researchers have found the virus targets 332 proteins in human cells and are looking for drugs that interfere with that process.