TrialSite has followed favipiravir with interest as this antiviral drug, originally from Japan, is approved and registered as a treatment for COVID-19 in multiple countries, including Russia, India, China and Bangladesh. We recently reported that original branded sponsor FUJIFILM Toyama Chemical Co., Ltd was gearing up to register the drug as a therapy for COVID-19 (it’s already approved for influenza). Recently, clinical trials in both Russia and Japan further evidence at least moderate efficacy. TrialSite reported Russia’s ChemRar Group, in partnership with the Russian Direct Investment Fund registered a favipiravir-based drug called Avifavir in that country as a treatment for COVID-19. Now the partnership that registered the world’s first COVID-19 treatment will supply the drug to dozens of countries.
TrialSite has been one of the few media platforms chronicling the research and clinical testing of favipiravir-based drugs around the world since the start of the pandemic. The antiviral drug has been approved, or is formally accepted as a COVID-19 therapy in Russia, India, China, Bangladesh and others. The drug is currently under investigation in the United States.
Earlier in September, TrialSite wondered can Favipiravir compete against Remdesivir? After all, the U.S. DoD must have seen something in this drug given it put up a total of at least $211.3 million just five years ago to fund clinical trials.
Clearly, Russia saw promise as they approved a generic version called Avifavir, while India has now several generic versions in pharmacies. TrialSite continued to ask the question, however: what is the real efficacy data? Apparently, there is enough data from research to convince regulators to move forward but in the age of COVID-19, where speed is the name of the game in drug development, the questioning must continue. TrialSite provides some summary data in articles such as here.
Avifavir, again a Russian version of favipiravir, was registered as an approved pharmaceutical product for COVID-19 on May 29, 2020. At that point it became the first favipiravir-based drug in the world approved for the treatment of COVID-19.
According to Russian-originated press releases, the efficacy of Avifavir has been demonstrated in clinical trials which significantly exceed in scale those conducted by other Russian manufacturers of favipiravir. These trials, again according to a ChemRar Group and RDIF joint press release, have been conducted in full compliance with international standards and the requirements of regulatory authorities around the world. Since April, 408 patients with confirmed coronavirus have participated in the studies at 35 medical centers across Russia. In October the number of patients will increase to 460.
In the recent Fujifilm Japan-based Phase 3 trial it was revealed that the median value of primary endpoints, using 156 individuals as analysis targets, were 11.9 days for the Avigan group and 14.7 days for the placebo group. Fujifilm confirmed, with a statistically significant difference (p value = 0.0136), that the administration of Avigan to COVID-19 patients with non-serious pneumonia demonstrates shorter time to resolution. The adjusted hazard ratio showed 1.593 (95% confidence interval of 1.024-2.479). No new safety concerns were observed in this trial
According to the results of a observational post-registration clinical trial of 940 patients, those taking Avifavir demonstrated elimination of the virus at an earlier stage in 30% of the cases and the level of oxygen saturation was restored to normal twice as quickly compared with standard therapy (within two days versus four days). According to the results of the research, the drug is well tolerated, with no new adverse events identified.
Russian Distribution Claims
Since June 2020, more than 60,000 packages of Avifavir have been delivered to clinics in 74 Russian regions. Since the start of Avifavir supplies, clinical monitoring has been carried out based on data from the register of patients with coronavirus of the Ministry of Health of Russia. Data on the use of Avifavir has been collected, with further analysis as well as scientific and medical assessment conducted.
Avifavir is now the leading Russian anti-COVID drug in terms of exports. In particular, the start of deliveries to Bolivia and other countries in Latin America was announced on September 21 as part of the agreement to deliver 150,000 packs. Avifavir has also been approved by regulators in Europe, Middle East and Asia.