Coronavir to Become the First COVID-19 Medicine Available in Pharmacies

23 September 2020

GMP News

The R-Pharm group of companies has announced the approval of Coronavir (INN: favipiravir) for out-patient treatment of mild to moderate COVID-19 coronavirus infection. According to the marketing authorization issued (LP-006323), Coronavir has emerged as the first medicine for coronavirus infection in Russia to make it to pharmacies, becoming available to a broad population of out-patients.

The approval was granted based on the final results of a phase 3 clinical trial conducted in mild to moderate COVID-19 patients observed both in community and hospitalized segments. The trial involving 168 COVID-19 patients demonstrated that Coronavir reduces median time to clinical improvement (using the WHO Ordinal Scale for Clinical Improvement) in patients with novel coronavirus infection by 4 days, and by 8 days in the cohort of out-patients. It is noteworthy that on day 7 clinical improvement in the Coronavir arm was achieved in more than 50% patients, which is 1.5 times higher than in the reference arm where conventional treatment was used, including either chloroquine derivatives or umifenovir combined with intranasal interferon alpha. Coronavir administration also resulted in statistically significantly more frequent SARS-CoV-2 coronavirus elimination from the oropharyngeal mucous membrane at early stages of the disease, i.e. by Days 3 and 5 after treatment initiation: on Day 3 viral elimination was achieved in 71.4% vs 57.1% in the reference arm, and on Day 5 – in 81.2 vs 67.9%.

Importantly, Coronavir has demonstrated a favorable safety profile. Most study subjects tolerated the treatment well, with asymptomatic uric acid elevation (observed in 41.7% patients) being the only specific adverse effect related to the medication, predominantly mild and resolving after treatment completion.

Based on the available results, Coronavir (favipiravir), developed by the R-Pharm group of companies, can be viewed as one of the most promising medicines to treat COVID-19 coronavirus infection.

“Our common mission is to make this product with proven efficacy available to every patient in need, whether treated at a hospital or isolated at home”, – emphasized Alexey Repik, R-Pharm board of directors Chairman.

“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”, – said Mikhail Samsonov, R-Pharm medical department Director.

 “The emergence of Coronavir in the out-patient segment is quite important for us. The use of this medicine during the very period when viral load is at its peak, according to the current messaging, will prevent immune-mediated issues that have dramatic consequences for some patients”, – mentioned Dr. Natalia Kostina, PhD, chief external pulmonologist of the Voronezh region healthcare department.

Coronavir manufacturing, organized with contribution from the Industrial Developmental Fund, takes place at R-Pharm premises in the city of Yaroslavl. All released packages are labeled with Data Matrix codes, giving pharmacy customers the opportunity to check the product with a “Chestny znak” mobile application which will display all the necessary information, including the drug manufacturer and expiry date.

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