Glenmark Pharma gets nod to launch favipiravir for Covid-19 patients

Glenmark is conducting phase-3 clinical trials; drug has got restricted emergency use

Antiviral oral drug favipiravir on Friday received the nod from the Indian drug regulator to be launched in the domestic market to treat mild-to-moderate patients of Covid-19. 

Mumbai-based drug major 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 Gilead’s remdesivir some time back based on the clinical trial data presented by the company. 

The Drug Controller General of India (DCGI) has given manufacturing and marketing approval to Glenmark to launch oral favipiravir (under brand name FabiFlu) to treat mild to moderate Covid-19 patients. 

The approval has been granted based on evaluation of data and in consultation with the subject expert committee, as part of the accelerated approval process. This is 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, a local player Brinton Pharma, which is exporting the drug to several countries, has priced it around Rs 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 indicated that once some concrete data arrives from the ongoing clinical trials, the drug approval process can be expedited. “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.

In the absence of clinical trial data, the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) can review an application to consider approving a drug. 

The drug will be given under supervision of doctors in hospitals. 

“They can be made available at chemist shops, but selectively. Gradually, the oral drugs could be made available at chemists upon providing a valid prescription,” said the official. Favipiravir is a generic drug and has been in use for different types of influenza for years.