Russia has granted marketing authorisation for R-Pharm’s Covid-19 prescription drug, Coronavir, to treat outpatients with mild to moderate infection.
The antiviral drug became the first coronavirus drug distributed in pharmacies in Russia. A favipiravir product, Coronavir directly targets the virus and blocks its replication.
Coronavir’s approval comes from the final data obtained during a Phase III clinical trial performed in patients with mild to moderate Covid-19 in community and hospitalised settings.
In the 168-participant trial, the drug led to a decrease in median time to clinical improvement in Covid-19 patients by four days and in a cohort of outpatients by eight days.
On day seven, more than 50% of patients on Coronavir experienced clinical improvement, 1.5 times higher compared to the reference arm of standard treatment.
R-Pharm’s drug also demonstrated statistically significantly more frequent SARS-CoV-2 elimination from the oropharyngeal mucous membrane at the early stages of the disease.
On day three, researchers observed viral elimination in 71.4% of patients in the study drug group compared to 57.1% in the reference arm, and on day five, in 81.2% versus 67.9%, respectively.
Furthermore, Coronavir showed a favourable safety profile, with most participants tolerating the treatment well. The only specific adverse effect related to the drug was an asymptomatic uric acid elevation.
R-Pharm medical department director Mikhail Samsonov said: “According to the clinical trial evidence, Coronavir, when administered in a timely manner early during the disease course, has demonstrated the best efficacy among all medicines used by now.”
Supported by the Industrial Developmental Fund, the drug’s manufacturing takes place at R-Pharm site in Yaroslavl city.
In June, Russia granted temporary approval to Covid-19 treatment, Avifavir, produced by the Russian Direct Investment Fund (RDIF) and ChemRar Group.
Separately, the European Medicines Agency’s human medicines committee (CHMP) recommended dexamethasone as a treatment option for adult and adolescent Covid-19 patients needing oxygen therapy.
The CHMP recommendation comes after a review of results from the RECOVERY trial. The UK Government already authorised the use of dexamethasone to treat Covid-19 on the National Health Service (NHS) in June.