Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg, the generic version of Qtern®1 Tablets, 10 mg/5 mg, of AstraZeneca AB.

According to IQVIA™ sales data for the 12 month period ending February 2020, the Qtern® Tablets, 10 mg/5 mg market2 achieved annual sales of approximately $10.4 million*.

Glenmark's current portfolio consists of 162 products authorized for distribution in the U.S. marketplace and 44 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

In another developement,Glenmark Pharmaceuticals, received approval from the DCGI (Drug Controller General of India), the regulator in India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 patients. The product is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation.

Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently in the past few months, post the outbreak of COVID-19, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US.

Having internally developed the API and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomized 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 maximum for 28 days from randomization.

"After having successfully developed the API and the formulations through its in-house R&D team, Glenmark 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," said Sushrut Kulkarni, Executive Vice President - Global R&D, Glenmark Pharmaceuticals Limited. He also added, "If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients."