Glenmark Pharmaceuticals on Saturday launched antiviral drug Favipiravir for treatment of mild-to-moderate COVID-19 cases after it received the Indian drug regulator’s approval.
It will be available under the brand name FabiFlu as a prescription-based medication for Rs 103 per tablet, with recommended dose of 1,800 mg twice a day on day 1 and 800 mg twice a day up to 14th day, according to the Mumbai-headquartered global pharmaceutical company.
Glenmark received the approval for manufacturing and marketing Favipiravir from the Drugs Controller General of India (DCGI) on Friday.
“The approval has come at a time when cases in India are spiralling, putting tremendous pressure on our healthcare system,” Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals, said in a statement.
“We hope the availability of an effective treatment, such as FabiFlu, will help assuage this pressure considerably and offer patients in India a much-needed and timely therapy option,” Saldanha said.
Favipiravir is backed by strong clinical evidence, showing encouraging results in patients with mild to moderate Covid-19. It offers broad spectrum RNA virus coverage with clinical improvement noted in 20-90 plus age group.
Patients from over 10 leading government and private hospitals were enrolled for the study.
Favipiravir could be used for Covid-19 patients with comorbid conditions, like diabetes and heart disease, the company said and added, it would offer rapid reduction in viral load within four days, and faster symptomatic and radiological improvement.
Glenmark has developed the active pharmaceutical ingredient (API) and formulation for FabiFlu through in-house R&D team.
Glenmark was the first company in India to receive the drug regulator’s approval to conduct phase-3 clinical trial of Favipiravir antiviral tablets for Covid-19 patients.
Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical, Japan, a subsidiary of Fujifilm Corporation.