Russia has approved R-Pharm's Coronavir treatment for outpatients with mild to moderate COVID-19 infections and the antiviral drug could be rolled out to pharmacies in the country as soon as next week, the company said on Friday.
Coronavir's approval as a prescription drug follows the green light for another Russian COVID-19 drug, Avifavir, in May. Both are based on favipiravir, which was developed in Japan and is widely used there as the basis for viral treatments.
R-Pharm's announcement is another sign Russia is pushing hard to take a global lead in the race against the virus. It is already exporting its COVID-19 tests and has clinched several international deals for supplies of its Sputnik-V vaccine.
R-Pharm said it received approval for Coronavir after Phase III clinical trials involving 168 patients with COVID-19.
The drug was first approved for in-hospital use to treat COVID-19 in July, a government register showed.
Coronavir's trial was comparatively small. The European health regulator on Friday endorsed the use of the steroid dexamethasone in the treatment of COVID-19 patients after a study by UK researchers on several thousand patients.
R-Pharm has started talks with pharmacies about orders, the company's spokeswoman said, with Coronavir supplies expected to be rolled out shortly, possibly as soon as next week.
Coronavir is made at R-Pharm's facility in Yaroslavl, about 300 km (186 miles) northeast of Moscow.
Avifavir has been available in hospitals since June but has yet to be supplied to pharmacies.
Both are based on the active ingredient favipiravir, which is also the key component in Fujifilm Holdings Corp's antiviral drug Avigan, approved in Japan as an emergency influenza treatment in 2014.
Trials to test it against COVID-19 are ongoing around the world. Results of a Japanese study in July were inconclusive.
It is produced by various Indian generic drugmakers including Lupin, Cipla, and Dr. Reddy's for use against COVID-19 in India.