Glenmark Pharmaceuticals on Thursday said it has become the first company in India to receive approval from Drug Controller General of India (DCGI) to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients.
Having internally developed the active pharmaceutical ingredients (API) and the formulations for the product, the company filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients, Glenmark Pharmaceuticals said in a statement.
The Mumbai-based company is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in the country, it added.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections, it added.
As per the clinical trial protocol approved, 150 subjects 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, the company said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
In the past few months, following the outbreak of COVID-19, multiple clinical trials have been initiated on such patients in China, Japan and in the US.
The drug firm said its product is a generic version of Japan-based Fujifilm Toyama Chemical Co Ltd's Avigan tablets.
Glenmark Pharmaceuticals Executive Vice President - Global R&D - Sushrut Kulkarni said the company 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. If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients," he added.Shares of the company were trading at Rs 346.80, up 5.19 percent from their previous close on BSE.