India-based Glenmark Pharmaceuticals, (Mumbai headquartered) has successfully received the approved by the Drug Controller General of India (DCGI), so as to manufacture and sell the antiviral drug Favipiravir to treat COVID-19 patients. The drug will be available in the next few days. Favipiravir is an antiviral drug and approved in Japan as a flu treatment. The limited use of approval entails responsible use of the drug, which requires all patients to sign an informed consent form before starting treatment.
As per the press release that was circulated on Saturday, 20th June 2020 by Glenmark, the company has successfully developed the FabiFlu’s APIs (active pharmaceutical ingredients) and other formulations with the help of its own R&D team. Well, what is a bonus here is that the government as well is conducting trials to test the efficacy of this drug. Council of Scientific and Industrial Research (CSIR) had done end-to-end synthesis of Favipiravir in April. Prior to this week, CSIR also got the consent from the Drug Controller General of India (DGCI) to perform multi-centre Phase-II trials of the drug.
Glenmark has put forward its claim that Favipiravir has shown a clinical progress which was characterized by up to 88% improvement in COVID-19 patients. The drug has further quickly brought down the viral load to just 4 days. This drug is available as a prescription for Rs 103/tablet and the suggested dosage is 1800 mg twice on the very first day, which is to be followed by 800 mg dose taken twice a day, up to the next 14 days.
In India, a randomized multicenter study was conducted to test the efficacy and safety of drugs with only treatment standards and treatment standards in mildly moderate COVID-19 in Indian patients, the company said. This multicenter study has registered approx. 150 patients. Research details are not yet published in peer review papers.
The company has quoted four studies in its press release. One of the studies conducted on 2 patients in China, 1 in Russia and Japan, and 80 in China studied the efficacy of anti-retroviral drugs Lopinavir and Ritonavir. Favipiravir treatment was successful in instantly reducing the viral load as compared to other relevant drugs. Further, in the second Chinese study, there were nearly 236 patients registered who underwent the trial.
Favipiravir had a better clinical recovery rate on day 7 compared to other antiviral drugs (Umifenovir). It was also relieved faster from fever and cough. A clinical improvement with Favipiravir was seen in a Japanese observational study of 2,141 patients with mild to moderate symptoms.
