Jahnavi Sarma
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Written By: Jahnavi Sarma | Published : June 20, 2020 11:32 AM IST
To combat the deadly COVID-19 contagion, scientists are looking at existing drugs and a few clinical trials are already underway.
The Drug Controller General of India has granted Glenmark Pharmaceuticals the manufacturing and marketing approval to launch the oral anti-viral drug Favipiravir (FabiFlu) for the treatment of mild to moderate COVID-19 patients in the country. This approval comes on the basis of the evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical needs of the COVID-19 outbreak, Glenmark said. Earlier, the regulatory body had approved Favipiravir for the second phase of clinical trials, and multi-centre trials were underway across different locations, including Mumbai and Pune.
This drug is meant for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation. Glenmark was the first pharmaceutical company in India to be given approval by the drug regulator to conduct Phase 3 clinical trial of Favipiravir antiviral tablets for Covid-19 patients. Patients from over 10 leading government and private hospitals were enrolled for the study. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Glenmark has successfully developed the API and the formulations for the product through its inhouse R&D team.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. The molecule, if commercialised, will be marketed under the brand name FabiFlu in India.
Favipiravir is an antiviral drug for emergency use against COVID-19. Scientists at CSIR were banking on data from clinical trials in Russia, where the FDA has approved the drug and their own partial data. Favipiravir is also being used to treat new influenza viruses in Japan. It is the generic version of the drug Avifavir, originally sold in Japan under the brand name Avigan. This is a pyrazine carboxamide derivative and can treat other viral infections. One of the repurposed drugs, Avifavir could shorten recovery time for patients with coronavirus.
Along with Favipiravir, there are other drugs, which are now in clinical trials. These are ACQH, Umifenovir (Arbidol) and Mycobacterium W (anti-leprosy drug). The focus is now on repurposed drugs and there are about 10 in the basket so far. Favipiravir and Umifenovir (Arbidol) are the drugs approved by the Drug Controller General of India (DCGI) for clinical trials to treat Covid-19, at Council of Scientific and Industrial Research (CSIR).
Mycobacterium W is used in the treatment of leprosy and CSIR has tied up with Cadila Pharmaceuticals to check for its efficacy in treating COVID-19. The Umifenovir drug prevents entry of viruses into human cells. It also boosts the immune system and is used for the treatment of influenza. Clinical trials to evaluate its efficacy are also underway. Multicentre clinical trials of phytopharmaceutical ACQH have also begun. It is a plant extract found in the tribal belts of Gujarat, Jharkhand and Madhya Pradesh.
(With inputs from Agencies)
