Glenmark Gets DCGI Approval To Conduct Clinical Trials Of Favipiravir Anti-Viral Tablets On Covid-19 Patients

Glenmark Pharmaceuticals has announced that it has received approval from the Drug Controller General of India (DCGI) to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 patients in the country, the company said on Thursday (30 April).

Favipiravir, a generic version of Japanese firm Fujifilm Toyama Chemical Co’s Avigan, has demonstrated activity against influenza viruses. It has been approved in Japan for the treatment of novel influenza virus infections. Multiple clinical trials had been initiated on COVID-19 patients, post the outbreak, in China, Japan and in the US.

“Having internally developed the API and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients,” the company said in a release.

Glenmark further said that it is the first pharmaceutical company in India to be given approval by the regulator to start the trial on COVID-19 patients

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 treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization, the release said.

“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,” said Sushrut Kulkarni, Executive Vice President, Global R&D, Glenmark Pharmaceuticals Limited.

“If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients,” he added.