Russia granted approval to a drug for use against COVID-19, the first time authorities have given the green light to a medicine against the new disease caused by the CCP (Chinese Communist Party) virus.
Hospitals can soon begin giving favipiravir, a drug traditionally used against the flu, to patients in early June after approval by Russia’s Ministry of Health, the Russian Direct Investment Fund (RDIF), and ChemRar Group said on Saturday.
Avifavir, Russia’s version of the drug, “is the first Russian direct antiviral drug that has proven effective in clinical trials,” RDIF said in a statement. The drug “has shown high efficacy in treating patients with coronavirus during clinical trials,” it added.
Intermediate data from clinical trials testing the drug against COVID-19 helped convince officials to issue temporary approval.
“Afivavir is not only the first antiviral drug registered against coronavirus in Russia, but it is also perhaps the most promising anti-COVID-19 drug in the world,” Kirill Dmitriev, RDIF’s CEO, said in a statement.
An “unprecedentedly short period of time” of development and testing in Russia enabled afivavir to become the first registered drug based on favipiravir in the world, he added.
Some 60,000 courses are being delivered to hospitals around the country this month, with the first batches going to Russia’s Federal Service for Surveillance in Healthcare. The first deliveries are slated for June 11.
Russians won’t have to pay for the drug.
Avifavir disrupts the reproduction of the CCP virus, health officials said. One trial found a median recovery time of four days versus nine with standard therapy, along with an impact on body temperature and days to testing negative.
Avifavir showed no new or previously unreported side effects, researchers said.
The drug was linked to fetal deaths in animal studies.
More trials involving the Lomonosov Moscow State University and other institutions are ongoing.
No vaccine exists for the CCP virus and scientists around the world are racing to prove the efficacy and safety of existing and experimental treatments against COVID-19.
Remdesivir and hydroxychloroquine have both shown positive results in some patients. Concerns about the former’s efficacy cropped up, while side effects for the latter indicate the need to avoid giving it to certain groups.
Avifavir, also known as Avigan, was developed by Japanese researchers a few decades ago. Fujifilm’s healthcare arm held the patent but it expired last year, enabling outside development of the medicine.
Fujifilm said last month it was boosting production of the drug after researchers in China found it was effective against COVID-19.
Researchers in a number of other countries, including Egypt and the United States, have also been testing the drug against the new disease.