Glenmark becomes India's first pharmaceutical company to receive regulatory approval for oral antiviral Favipiravir, for mild to moderate COVID-19 treatment

Considering the emergency situation of the COVID-19 outbreak in India, production and marketing approval granted as part of an accelerated approval process

Glenmark becomes India's first pharmaceutical company to receive regulatory approval for oral antiviral Favipiravir, for mild to moderate COVID-19 treatment

Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical group, announced the launch of antiviral medication Favipiravir (brand name FabiFlu ®) for the treatment of mild to moderate COVID-19 patients in a landmark breakthrough for COVID-19 patients in India on 20th June 2020. Glenmark has received manufacturing and marketing authorisation from India 's drug regulator, making FabiFlu ® India's first oral Favipiravir-approved medication for COVID-19 treatment.

The share of drug company Glenmark Pharmaceuticals increased by as much as 10 percent on June 22, 2020, following the launch of antiviral medication favipiravir to treat patients with mild to moderate symptoms of Covid-19. The drug Favipiravir was held at a price of about Rs 103 per pill, under the brnad label FabiFlu.

Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral provides wide spectrum coverage of RNA virus with clinical progress observed across 20 to > 90-year age groups. Favipiravir with mild to moderate COVID 19 symptoms should be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease. It offers rapid viral load reduction within 4 days and provides most significant symptomatic and radiological improvement, Favipiravir showed clinical improvement of up to 88 percent in COVID-19 mild to moderate COVID 19 cases.

Glenmark has successfully developed the active pharmaceutical ingredient ( API) and the FabiFlu ® formulations through its own internal R&D team. Glenmark submitted the product to India 's drug regulator DCGI for clinical trial and became India's first pharmaceutical company to receive approval for phase 3 clinical trials on mild to moderate COVID-19 patients.

Commenting on the significance of this development, Mr. Glenn Saldanha, Glenmark Pharmaceuticals Ltd. Chairman and Managing Director, said, "This approval comes at a time when cases in India are spiraling like never before, putting tremendous pressure on our health care system. We hope that the availability of effective treatment such as FabiFlu ® will help greatly in counteracting this pressure and offer patients in India a much-needed and timely treatment option.”

Glenn Saldanha added, "During clinical trials, FabiFlu ® had shown an encouraging response in mild to moderate COVID-19 patients. It is also offered orally, and thus acts as a more convenient treatment choice compared to other intravenously administered medicines. Glenmark will work closely with the government and medical community to make FabiFlu ® easily available to patients across the country.”

Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical group, announced the launch of antiviral medication Favipiravir (brand name FabiFlu ®) for the treatment of mild to moderate COVID-19 patients in a landmark breakthrough for COVID-19 patients in India on 20th June 2020. Glenmark has received manufacturing and marketing authorisation from India 's drug regulator, making FabiFlu ® India's first oral Favipiravir-approved medication for COVID-19 treatment.

The share of drug company Glenmark Pharmaceuticals increased by as much as 10 percent on June 22, 2020, following the launch of antiviral medication favipiravir to treat patients with mild to moderate symptoms of Covid-19. The drug Favipiravir was held at a price of about Rs 103 per pill, under the brnad label FabiFlu.

Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral provides wide spectrum coverage of RNA virus with clinical progress observed across 20 to > 90-year age groups. Favipiravir with mild to moderate COVID 19 symptoms should be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease. It offers rapid viral load reduction within 4 days and provides most significant symptomatic and radiological improvement, Favipiravir showed clinical improvement of up to 88 percent in COVID-19 mild to moderate COVID 19 cases.

Glenmark has successfully developed the active pharmaceutical ingredient ( API) and the FabiFlu ® formulations through its own internal R&D team. Glenmark submitted the product to India 's drug regulator DCGI for clinical trial and became India's first pharmaceutical company to receive approval for phase 3 clinical trials on mild to moderate COVID-19 patients.

Commenting on the significance of this development, Mr. Glenn Saldanha, Glenmark Pharmaceuticals Ltd. Chairman and Managing Director, said, "This approval comes at a time when cases in India are spiraling like never before, putting tremendous pressure on our health care system. We hope that the availability of effective treatment such as FabiFlu ® will help greatly in counteracting this pressure and offer patients in India a much-needed and timely treatment option.”

Glenn Saldanha added, "During clinical trials, FabiFlu ® had shown an encouraging response in mild to moderate COVID-19 patients. It is also offered orally, and thus acts as a more convenient treatment choice compared to other intravenously administered medicines. Glenmark will work closely with the government and medical community to make FabiFlu ® easily available to patients across the country.”