Glenmark to launch higher strength Favipiravir to reduce pill-burden to patients

Our Bureau Mumbai | Updated on August 06, 2020

Drugmaker Glenmark Pharmaceuticals is set to introduce antiviral favipiravir at a higher strength (400 mg), for the treatment of mild to moderate Covid-19 in India. This will improve patient compliance by reducing the number of tablets that patients require per day.

“A higher pill burden has been associated with lower adherence to therapy, the latter affecting viral suppression and overall treatment outcomes. Also reducing the pill burden has been a demand from doctors and patients to enable adherence,” a statement from Glenmark said. The drug is expected to be available in a week.  

Glenmark’s favipiravir, sold as brand FabiFlu (200 mg),  required patients to take 18 tablets on Day 1 (nine in the morning and nine in the evening), followed by eight tablets each day after that for a maximum of 14 days. The higher strength - 400 mg version - halves the dosage regimen for patients, with nine tablets on Day 1( 4.5 in the morning and 4.5 in the evening), and thereafter two tablets twice a day till the end of the course.

The development comes even as doctors have had differing views on benefits from the drug to Covid-19 patients. But Dr Shashank Joshi, who is on Maharashtra’s Covid taskforce, told Business Line that the drug had its advantages, mainly when used in early days of the treatment. “It shows viral clearance and is useful in Covid and for flu. The local data is compelling, and it can break the transmission cycle,” he said, adding that it should be used early. “Hit hard and hit early,” he said, on using the drug within the first three days of treatment. 

“We have to get over the colonial mindset and trust data emerging from Asia and India,” he said, adding that the drug was being used in Japan, China, Russia and by doctors in India. 

Several Indian drug companies have also come out with their versions of Favirpiravir (200), including Sun Pharma, Lupin, Hetero, BDR Pharma, etc., even as several others prepare to launch.  

Dr Monika Tandon, Glenmark Pharma ‘s Vice President and Head ( Clinical Development - Global Specialty/Branded Portfolio) said, the 400 mg version was a result of Glenmark’s own research and development efforts to improve the treatment experience for patients in India.  

Meanwhile, Glenmark has also commenced a Post Marketing Surveillance (PMS) study on FabiFlu (200mg) to monitor the efficacy and safety of the drug in a large pool of patients prescribed with the oral antiviral Favipiravir,  as part of an open-label, multicenter, single-arm study, the company said.  The company is also conducting another late-stage trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult Covid-19 patients in India. 

The combination study called the FAITH trial is looking to enrol 158 hospitalized patients of moderate COVID-19 in India. Early treatment with the combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening duration of virus shedding, facilitating early clinical cure and discharge of patients, Glenmark said.

Published on August 06, 2020

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