Glenmark gets nod for favipiravir; Cipla, Hetero for remdesivir

Two vital drugs to treat Covid-19 patients got the drug regulator's nod on Friday. While Glenmark Pharma got the Drug Controller General of India’s (DCGI’S) approval to launch oral antiviral favipiravir, Maharashtra Health Minister Rajesh Tope claimed Cipla and Hetero also received the nod for Gilead’s repurposed drug remdesivir.

Mumbai-based Glenmark Pharmaceuticals is conducting phase-iii clinical trials to assess the drug’s efficacy on Covid-19 patients. The drug may be available as early as next week, claimed sources.

India had given nod to remdesivir some time back based on the clinical trial data presented by the company. Now, two Indian licensees — Hetero and Cipla — got the nod to launch the drug in the domestic market. Cipla refused to comment. Hetero could not be immediately reached for a comment.

The remdesivir approval was expected anytime now after the firms had submitted requisite data on stability and toxicology. Sources had earlier indicated that the drug might be available in the market within this month and was likely to be priced around ~5,000 a dose. Each patient would need around 11 doses.

Maharashtra was keen to get remdesivir to treat patients and was also looking at options to import it from Bangladesh.

Meanwhile, the DCGI has given manufacturing and marketing approval to Glenmark to launch oral favipiravir (under brand name

Fabiflu) to treat mild-tomoderate Covid-19 patients. The approval has been granted based on evaluation of data and in consultation with the subject expert committee, considering the emergency situation and unmet medical need of the Covid-19 outbreak, a company spokesperson confirmed.

He said the drug was for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation. While the company did not wish to divulge pricing of the drug, Brinton Pharma, which is exporting the drug to several countries, has priced it around ~2,500 for a strip of ten tablets.

In the first week of June after Russia approved use of avifavir, a derivative of Favipiravir, for treatment of Covid-19, India worked to ensure the antiviral drug is available here soon. A source said almost 100 companies were ready to launch favipiravir in the country once Glenmark presents its data.

Senior government officials had said the drug approval process could be expedited once they got some concrete data from the ongoing clinical trials.

“Until there is a definite benefits exhibited by a drug, we cannot put patients at risk. Therefore, we are taking a judicious approach,” an official had said.