India-based Glenmark Pharmaceuticals has commenced phase 3 clinical studies on antiviral tablet Favipiravir for Covid-19 patients in the country.
The company has secured approval from the Drugs Controller General of India (DCGI) to begin the trial with Favipiravir at the end of April.
Favipiravir is a generic version of Avigan from Fujifilm Corporation subsidiary Fujifilm Toyama Chemical Co. Ltd., Japan.
Glenmark Pharmaceuticals global speciality/branded portfolio clinical development head and vice president Dr Monika Tandon 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 company has started enrolment of patients in phase 3 clinical trials at 10 major government and private hospitals in India. Glenmark aims to complete the study between July and August this year.
Glenmark has completed the development of active pharmaceutical ingredient (API) and the formulations for the product with the support of its in-house research and development (R&D) team.
According to the company, the Favipiravir has shown activity against influenza viruses, as well as approved in Japan to treat novel influenza virus infections.
Upon commercialisation, Glenmark is planning to market the molecule under the brand name FabiFlu in India.
Glenmark Pharmaceuticals Middle East and Africa, India formulations president Sujesh Vasudevan 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.”
In April, Novartis entered into an agreement with the US Food and Drug Administration (FDA) to conduct a clinical trial with the hydroxychloroquine in hospitalised Covid-19 patients.
Sponsored by Novartis, the trial will recruit around 440 patients to assess the efficacy of malaria drug to treat hospitalised patients with Covid-19 disease.