Mumbai-based Glenmark Pharmaceuticals today said it has been authorised by India’s Drug Controller General to perform clinical trials of antiviral medication favipiravir on patients with coronavirus.
The drug is a generic Fujifilm Toyama Chemical Co. version of Avigan. Japanese, Ltd. This news pushed shares in Glenmark up to 9 per cent higher today. As of today, Glenmark is India’s first pharmaceutical company to get regulator approval to launch the COVID-19 patient trial in India. As per the approved clinical trial protocol, the study will randomize 150 subjects with mild to moderate COVID-19 in a 1:1 ratio to Favipiravir with normal supportive care or non-standard supportive care.
The period of treatment is a maximum of 14 days and the overall length of the test will be a maximum of 28 days from randomisation, the company said. Another Indian pharmaceutical firm, Strides Pharma Science Ltd, said it had produced and commercialized antiviral favipiravir tablets on Wednesday and had applied to the authorities for trials to begin.
Sushrut Kulkarni, Executive Vice President of Global R&D, Glenmark Pharmaceuticals, said: “After successfully developing the API and formulations through its in-house R&D team, Glenmark is focused on starting clinical trials on Favipiravir on COVID-19 patients in India immediately. The clinical trial will let us know the effectivene17ss of this molecule on patients with COVID-19. The efforts and experiments of doctors and scientists are bringing us closer to possibly find a vaccine.