After DCGI's Nod, Glenmark Launches Anti-Viral Drug FabiFlu For Treatment Of Mild To Moderate Covid-19 Patients

Glenmark Pharmaceuticals on Saturday (20 June) announced the launch of anti-viral drug Favipiravir, brand name FabiFlu, for the treatment of mild to moderate COVID-19 patients, the company said in a statement.

Glenmark on Friday (18 June) had announced that it 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.

The company said that Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19.

"The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years," it said.

Glenmark developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team.

"Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients," the company said.

Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement, Glenmark said.

"Favipiravir has shown clinical improvement of up to 88 per cent in COVID-19 mild to moderate COVID 19 cases," the company added.

Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. The drug will be available as a prescription-based medication for Rs 103 per tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14, the company said.

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.”

“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," he added.