Domestic pharmaceuticals Glenmark on Saturday informed that their antiviral drug — Favipiravir — has shown clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases, including those with co-morbidities.
However, it said that pregnant and lactating mothers were not included in the clinical trial.
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The domestic pharma giant announced the launch of the first oral Favipiravir in the brand name “FabiFlu” claiming that it 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. 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,: the company said in its statement.
“It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement. Of most importance, Favipiravir has shown clinical improvement of up to 88 per cent in COVID-19 mild to moderate COVID 19 cases including those with co-morbidities,” the statement said.
On Friday, ANI had reported that the country’s top drug regulator has granted permission to anti-viral drug favipiravir for “restricted emergency use” in mild to moderate cases of COVID-19 in India, following which Glenmark Pharmaceuticals received manufacturing and marketing approval from the Drug Controller General of India (DCGI).
Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house Research and Development team, the pharma company said.
It filed the product for a clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase three 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 spiraling like never before, putting 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.
Notably, Favipiravir is has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections.
It has a unique mechanism of action as it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
The drug will be available as a prescription-based medication for Rs 103 per tablet, with the recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
Last month, Glenmark had also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.