Glenmark Pharmaceuticals Ltd said on Friday it had received an approval from India’s drugs regulator to make and sell oral antiviral drug favipiravir for treating mild-to-moderate COVID-19 patients in the country.
The Mumbai-based drugmaker said the approval was part of government’s accelerated approval process and the drug would be for “restricted emergency use” in the country.
Favipiravir is made under the brand name Avigan by Japan’s Fujifilm Holdings Corp and was approved for use as an anti-flu drug there in 2014.
FabiFlu is the first oral Favipiravir-approved medication for the treatment of Covid-19, the company said in a statement. “This approval comes at a time when cases in India are spiralling 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 pantients during clinical trials, Saldanha said. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications, he noted.
“Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country,” Saldanha said. The drug will be available as a prescription-based medication for Rs 103/tablet, with recommended dose being 1,800 mg twice on day one, followed by 800 mg twice daily up to day 14. Favipiravir can 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. It had then filed the product for clinical trial with country’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate Covid-19 patients.
Favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. Last month, Glenmark 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 hospitalised adult Covid-19 patients in India. 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, according to Union Health Ministry data.
