On September 21, 2020, Russia approved R-Pharm’s prescription drug Coronavir for the treatment of patients with mild to moderate COVID-19 infection. The antiviral drug is the first coronavirus drug to be introduced into pharmacies in Russia. Coronavir, a favipiravir product, targets the virus directly and blocks its reproduction.
The approval of Coronavir was based on final data obtained during a phase III clinical trial in patients with mild to moderate COVID-19 in the community and in the hospitals.
In the study of 168 participants, the drug reduced the median time to clinical improvement by four days in COVID-19 inpatients and by eight days in a group of outpatients.
On the seventh day, more than 50 percent of the patients reported a clinical improvement with Coronavir, which is 1.5 times higher than in the control group that was receiving standard treatment.
R-Pharm’s drug also showed statistically significant increased elimination of SARS-CoV-2 from the oropharyngeal mucosa in the early stages of the disease.
On the third day, virus elimination was observed in 71.4 percent of patients in the drug group, compared to 57.1 percent in the control group. On the fifth day, the virus was eliminated in 81.2 percent of subjects in the drug group, against 67.9 percent in the comparison group.
Coronavir also showed a favorable safety profile, with most participants tolerating the treatment well. The only specific adverse effect associated with the drug was asymptomatic uric acid elevation.
The head of R-Pharm’s medical department Mikhail Samsonov said, “According to the evidence from the clinical trial, if administered in time during the course of the disease, Coronavir has shown the best efficacy of any drug used to date.”
The drug will be manufactured at R-Pharm’s site in Yaroslavl with the support of the Industrial Development Fund.
In June this year, Russia granted temporary approval to Avifavir, a COVID-19 medicine produced by the Russian Direct Investment Fund (RDIF) and ChemRar Group.
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