BackMumbai company gets approval for clinical trial of drug on coronavirus patients
Glenmark said it has received approval for conducting the trial on mild to moderate patientsAnother Bangalore company has also applied to start clinical trials
PremiumMumbai-based Glenmark Pharmaceuticals today said has received approval from the Drug Controller General of India to conduct clinical trials of antiviral drug favipiravir on coronavirus patients. The product is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan. This news sent Glenmark shares as much as 9% higher today.
"Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently in the past few months, post the outbreak of COVID-19, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US," Glenmark said.
Glenmark said it has received approval for conducting the trial on mild to moderate patients.
"As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. 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. Treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization, the company said.
Sushrut Kulkarni, Executive Vice President – Global R&D, Glenmark Pharmaceuticals, said: “After having successfully developed the API and the formulations through its in-house R&D team, Glenmark 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."
He also added, “If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients."
Another Indian pharmaceutical company, Strides Pharma Science Ltd, said on Wednesday it had developed and commercialized favipiravir antiviral tablets, and had applied to the authorities to start trials.
In another development, preliminary results from a US government trial showing that patients given Gilead Sciences Inc's experimental antiviral drug remdesivir recovered faster than those given a placebo.
The U.S. Food and Drug Administration said it has been in discussions with Gilead about making remdesivir available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval.
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