The European Medicines Agency said Thursday it will start a rolling review of remdesivir, an investigational therapy for COVID-19 originally developed by drugmaker Gilead to treat Ebola.
The announcement from Europe’s top medicines body is likely to add momentum to the drug, signaling that regulators are taking the prospects of this potential therapy for the coronavirus seriously.
Rather than wait for the U.S. pharmaceutical company to collect all of its clinical data in one regulatory submission, the EMA said it will review the information as it comes along.
“[Rolling review] does not imply that its benefits outweigh its risks,” the drugs watchdog noted.
The purpose of the exceptional practice is to speed up the regulatory process compared with a regular evaluation procedure, the EMA said.
The decision to go ahead with the review is based on preliminary data from a U.S. clinical trial in which the drug showed some positive effects, the regulator said.
The EMA added it will also look at a Chinese study in which the drug failed to provide evidence of “significant clinical benefits.”
Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, has praised the preliminary positive results of the U.S. study, comparing it to the discovery of the first medicine found to help treat HIV more than three decades ago.
“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recover,” Fauci told reporters Wednesday.