Guwahati: Glenmark Pharmaceuticals became India’s first pharmaceutical company to receive regulatory approval for oral antiviral Favipiravir, for the treatment of mild to moderate COVID-19
The pharmaceutical company based in Mumbai received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) on Friday.
Glenmark will market the antiviral under the brand name FabiFlu.
FabiFlu is the first oral Favipiravir-approved medication for Covid-19, the company said in a statement. “The approval comes at a time when cases in India are spiraling like never before, putting a tremendous pressure on our healthcare system,” Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said.
The company hopes that 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, he added.
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, he noted.
Saldanha said that Glenmark would work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country.
The drug will be available as a prescription-based medication for around Rs 103 per tablet, with recommended doses up to day 14.
The company claimed that Favipiravir could be used for coronavirus 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 four days and provides faster symptomatic and radiological improvement, the drug maker added.
Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate Covid-19 cases, it said.
The drug firm had successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its in-house R&D team.
According to Union Health Ministry, India on Saturday saw another record spike of 14,516 new Covid-19 cases in a single day, pushing the tally to 3, 95, 048, while the death toll rose to 12,948 with 375 new fatalities till filling of this report.