Corona Vaccine: DCGI approves the clinical trial of “Favipiravir” for COVID-19 patients in India
DELHI: With a continuous increase in Coronavirus cases around the World, there have been many on-going research projects for the development of a vaccine to combat the deadly virus. Along with various researches abroad, there have been consistent efforts in India too. Earlier, this month it was informed in a meeting with the PM that nearly 30 vaccines are under different stages of development in the country.
Meanwhile, Glenmark Pharmaceuticals has received approval from the Drugs Controller General of India(DCGI) to start the clinical trial of an antiviral tablet Favipiravir. The company will initiate the third phase of the clinical trial of the medicine for the COVID-19 patients in India.
“Favipiravir” is a generic version of Avigan produced by Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. The medicine has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.
The molecule, if commercialised, will be marketed under the brand name ‘FabiFlu’ in India.
As per the approved clinical trial protocol, 150 patients with mild to moderate COVID-19 will be randomised 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 a maximum of 28 days from randomisation.
There are ten leading governments and private hospitals in India who have been enrolled for the study and are actively involved as the clinical trial commenced.
At present, it is estimated that the study would get completed by the end of July or August 2020. The company has developed the API and the formulations for the product through its in-house Research & Development team.
Monika Tandon, the Vice-President, Glenmark Pharmaceuticals Ltd., said in a statement, “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,” she added.
“The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” Ms. Tandon further said.
Meanwhile, the President of Glenmark Pharmaceuticals Limited,India Formulations, Middle East and Africa, Mr. 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,” he said.