Glenmark Pharmaceuticals has secured approval from India to launch Japan-based Fujifilm’s antiviral drug favipiravir under the brand name FabiFlu for the treatment of COVID-19 in patients with mild to moderate symptoms.

The Indian pharma company has been granted manufacturing and marketing approval from the Drug Controller General of India (DCGI), a department of the Central Drugs Standard Control Organisation (CDSCO), for the antiviral drug.

FabiFlu can be used in COVID-19 patients having co-morbid conditions like diabetes and heart disease with mild to moderate symptoms.

Supported by strong clinical evidence, favipiravir had delivered promising results in patients with mild to moderate coronavirus. The antiviral is said to give broad spectrum RNA virus coverage with clinical improvement observed across age groups 20 to >90 years.

Favipiravir is claimed to deliver rapid reduction in viral load within four days and provide quicker symptomatic and radiological improvement. Significantly, favipiravir has delivered clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases, said Glenmark Pharmaceuticals.

The pharma company said that it had developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house research and development team.

Glenmark Pharmaceuticals filed the antiviral product for clinical trial with DCGI and became the first pharmaceutical company in India to get approval for carrying out phase 3 clinical trial on mild to moderate COVID-19 patients.

Glenn Saldanha – Chairman and Managing Director of Glenmark Pharmaceuticals 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.

“FabiFlu has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country.”

FabiFlu will be available at pharmacies and sold under prescriptions at Rs 103 per tablet. The recommended dose of the COVID-19 drug is 1,800mg daily twice on Day 1, followed by 800mg daily twice up to Day 14.

In May, Glenmark Pharmaceuticals said that it is undertaking another clinical trial to assess the efficacy of the combination of favipiravir with another antiviral – umifenovir for the treatment of moderate hospitalized adult COVID-19 patients in India.

Favipiravir was approved in Japan in 2014 for the treatment of novel or re-emerging influenza virus infections.

  Central Drugs Standard Control Organisation, Coronavirus, COVID-19, Drug Controller General of India, FabiFlu, favipiravir, Glenmark Pharmaceuticals, Glenn Saldanha, India