Glenmark drug gets DCGI nod; claims 88% mild to moderate COVID-19 patients recovered during trials

Glenmark Pharmaceuticals has announced the launch of antiviral drug Favipiravir for the treatment of 'mild to moderate COVID-19 patients' after receiving manufacturing and marketing approval from India's drug regulator.

In a statement, the company said Favipiravir was 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.

As per the company, it offers a rapid reduction in viral load in four days and provides faster symptomatic and radiological improvement. The company said Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases.

According to the company, it's the first pharmaceutical firm in India to receive the approval for conducting phase three clinical trial on mild to moderate COVID-19 patients. "The approval comes at a time when cases in India are spiralling like never before, putting tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as Favipiravir considerably help assuage this pressure," Glenn  Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd, said.

Glenn said Favipiravir was orally administered, and so it served as a more convenient treatment option over other "intravenously administered medications". Glenmark will work closely with the government and medical community to make Favipiravir accessible to patients across the country, Glenn said.

Favipiravir was approved in Japan in 2014 for the treatment of novel or re-emerging influenza virus infections. The drug will be available as a prescription-based medication for  Rs 103 per tablet, with the recommended dose being 1,800 mg twice on day 1, followed by 800 mg twice daily up to day 14. Last month, Glenmark had also announced  that it was conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as combination therapy in moderate hospitalised adult COVID-19 patients in India.