Pharmaceutical and research company Glenmark has initiated Phase 3 of clinical trials of antiviral drug Favipiravir. In a BSE filing, the company stated that it is the first pharmaceutical company in the country to be granted approval by drug regulator Drug Controller General of India (DCGI) for Phase 3 of clinical trials. Glenmark stated that completion of the trials and declaration of results are likely to be done by August.
Glenmark said that the trials are being conducted across 10 government and private hospitals. According to the approval, 150 subjects who have mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio with Favipiravir and standard supportive care to standalone standard supportive care.
The treatment will go on for 14 days and Glenmark says it will take another 28 days for the study.
The antiviral Favipiravir is a generic version of Japanese company Fujifilm Toyama Chemical's Avigan drug. Glenmark has said that it has successfully developed the API and formulations for the product through its in-house research and development 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," it said.
Monika Tandon, VP and Head of Clinical Development in Glenmark said, "Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus. The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management."
Sujesh Vasudevan, President, India Formulations, Glenmark Pharmaceuticals said, "Our effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic. We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful."
With operations in over 50 countries. Glenmark's key focus areas are respiratory, dermatology and oncology.
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