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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataOn 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.
