Glenmark’s Clinical Trials On Favipiravir
Potential Treatment for COVID-19
In India, clinical trials on Favipiravir Antiviral tablets for Covid-19 patients begins after the regulator (DCGI) gave approval for an Indian drugmaker to proceed.
An integrated global and research-led pharmaceutical company, Glenmark Pharmaceuticals Ltd. announced that it has got approval to conduct trials with the drug favipiravir, an antiviral drug seen as a potential treatment for Covid-19 after which the company’s shares rose almost 9% on Thursday.
In 2014, the drug favipiravir was approved for use as an anti-flu drug in the Asian island country and was manufactured under the brand name Avigan by a unit of Japan’s Fujifilm Holdings Corp. At a news conference last month, a Chinese official said that in helping coronavirus patients recover, the favipiravir drug has been effective and has shown no obvious side-effects.
The executive vice-president for Global R&D of Glenmark Pharmaceuticals said in a statement that, “Glenmark is all geared up to immediately start clinical trials on favipiravir on Covid-19 patients in India, after successfully developing the API and the formulations. The efficacy of this molecule on Covid-19 patients will be known through this clinical trial. This drug could become a potential treatment for the patients affectedwith Covid-19 if the trials are successful.”
So far, to begin the trial on Covid-19 patients in India, Glenmark is the first pharmaceutical company to get approval by the regulator. In the study, there will be 150 subjects with mild to moderate Covid-19 and will be randomized in a 1:1 ratio to Facipiravir with standalone standard supportive care or standard supportive care, as per the clinical trial protocol. The total study duration will be for 28 days maximum from randomization and the maximum treatment duration will be for 14 days.
Strides Pharma Science Ltd., another Indian pharmaceutical company said on Wednesday that it had applied to Indian drug authorities to start trials after it had developed and commercialized favipiravir antiviral tablets.