New Delhi | Jagran News Desk: The Drug Controller General of India (DCGI) has approved the Mumbai-based Glenmark Pharmaceuticals to manufacture the anti-viral drug, Favipiravir, to treat the coronavirus patients across the country.
The approval was given after the 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. The DCGI had also given Glenmark permission to market the drug in the Indian market, which is expected to be available in the market in the next few days.
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 Glenmark on Saturday issued a press release in which the claimed that the drug shows clinical improvements of up to 88 per cent in Covid-19 patients. "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”.
"It offers a 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 further added.
“Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its in-house Research and Development team”, the pharma company said.
What is Favipiravir?
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 COVID-19 patients in India.
(With ANI Inputs)