Manufacturing and marketing approval granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India
- Manufacturing and marketing approval granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India
- The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation
- Favipiravir shows clinical improvements of up to 88% in COVID-19, with rapid reduction in viral load by 4 days
- Clinical improvement noted across age groups 20 to >90 years, including in patients with co-morbid conditions like diabetes and heart disease suffering from mild to moderate COVID-19
NEW JERSEY and MUMBAI, India, June 20, 2020 /PRNewswire/ -- In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, today announced the launch of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option.”
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team. Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. The drug will be available as a prescription-based medication, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. For more information, visit www.glenmarkpharma.com
References:
- https://rdif.ru/Eng_fullNews/5224/
- Furtuta Y et al. Antiviral Res. 2013;100(2):446-54.
- http://www.kansensho.or.jp/uploads/files/topics/2019ncov/covid19_casereport_en_200529.pdf
- Cai Q et al. Engineering (Beijing), 2020;10.1016/j.eng.2020.03.007
- Chen C et al. MedRxiv. 2020
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Company Codes: Bloomberg:GNP@IN, RICS:GLEN.BO, ISIN:INE935A01035
