Glenmark’s FabiFlu drug becomes the first one to be approved for COVID-19 treatment in India

DY365
DY365
Published: June 20,2020 11:20 PM
DY365

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June 20, 2020: Drug major Glenmark Pharmaceuticals has become the first Indian company to commercially launch an antiviral drug for the treatment of mild to moderate COVID-19 patients.

June 20, 2020: Drug major Glenmark Pharmaceuticals has become the first Indian company to commercially launch an antiviral drug for the treatment of mild to moderate COVID-19 patients, after it received the Indian drug regulator Drug Controller General of India (DCGI) approval for marketing and manufacturing.



On Saturday the firm said that it has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19.



A pack of 34 tablets of FabiFlu has been priced at Rs 3,500 (Rs 103 per tablet). The dosage is 200 mg X 9 tablets on day one and 200 mg X 4 tablets a day for 14 days of the treatment. However, it should only be taken after a doctor's prescription. A clinical trial was conducted  by Glenmark among 90 mild and 60 moderate Covid-19 patients across 11 sites in India. The drug is claimed to have an efficacy of over 80% in the treatment of mild to moderate COVID-19 patients. 



The active pharmaceutical ingredient (API) and the formulation for FabiFlu were developed by Glenmark through in-house research and development. The DCGI allowed fast track trials with Phase III in limited patients. The approval process is also under Emergency Use Authorisation (EUA).



Since the approval is under emergency category due to the pandemic, the patient has to give an undertaking before consuming the medicine.





"The approval comes at a time when cases in India are spiralling like never before and putting tremendous pressure on our healthcare system. FabiFlu will reduce this pressure. Glenmark will work with the government and medical community to make it quickly accessible to patients across the country," said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.