Mumbai-based Glenmark Pharmaceuticals on Thursday said it has become the first company in India to receive approval from the Drug Controller General of India (DCGI) to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients.
Having internally developed the active pharmaceutical ingredients (API) and the formulations for the product, the company filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients, Glenmark Pharmaceuticals said in a statement.
The Mumbai-based company is the first pharmaceutical company in India to be given approval by the regulator to start the trial on COVID-19 patients in the country, it added.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections, it added.
As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care, the company said.
Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomization, it added.
In the past few months, following the outbreak of COVID-19, multiple clinical trials have been initiated on such patients in China, Japan, and in the US.
The drug firm said its product is a generic version of Japan-based Fujifilm Toyama Chemical Co Ltd’s Avigan tablets.
Glenmark Pharmaceuticals executive vice president – Global R&D – Sushrut Kulkarni said the company is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India.
“The clinical trial will let us know the efficacy of this molecule on COVID-19 patients. If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients,” he added.
Shares of the company were trading at Rs 346.80, up 5.19 percent from their previous close on BSE.
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