Remdesivir is available in the United States on an emergency basis for hospital patients with severe cases of COVID-19, but FDA approval of Gilead’s new drug application would pave the way for wider use of the treatment. Remdesivir has already been approved for use in Europe and Japan.
The decision to get FDA approval for remdesivir comes nearly two months after Gilead announced positive results in a Phase 3 trial of the drug, which works by blocking replication of the virus. The study, conducted by the National Institute of Allergy and Infectious Diseases, was the drug’s second encouraging test.in the United States and Europe, which involved more than 1,000 inpatients, showed that treatment reduced recovery time for COVID-19 patients by nearly a third.
“Since the onset of the pandemic, Gilead has worked urgently to establish the efficacy and safety profile of Veklury, and we now have a strong data set to support the assessment of the drug’s use in a range of inpatient populations for COVID-19, ”Parsey says.
Gilead is best known for its treatments for HIV and hepatitis. Gilead Sciences’ stock price jumped 30% at the start of the pandemic earlier this year. But its shares have fallen more recently as a growing number of drug companies announce they are working on vaccines and other treatments to stop the spread of the coronavirus. The stock is now up just over 7% in 2020.
“Remdesivir isn’t a game-changer, but it’s a bright spot,” said Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner of the US Food and Drug Administration..
Last week, Goldman Sachs predicted in a report that the FDA would approveby the end of the year.
Aimee Picchi provided reporting for this story.