Drug firms get DGCI nod for Covid drug favipiravir despite inconclusive study

MUMBAI / HYDERABAD: Indian drugmakers’ interest in launching their versions of antiviral drug favipiravir as a treatment for Covid-19 has not waned even after a recent study said the drug’s efficacy in treating mild symptoms of the disease remains inconclusive.
On Tuesday, Hyderabad-based Biophore India Pharmaceuticals said it has received approval from the Drug Controller General of India (DGCI) to produce favipiravir as treatment for mild to moderate symptoms of Covid-19 for exports. The company is waiting for a nod from the drug controller to market the drug in India.

Interest in manufacturing the drug seems unaffected despite a recent study in Japan saying that the effectiveness of the drug in treating Covid-19 remains inconclusive.

There are at least four other Indian drug makers which are awaiting clearance from the DGCI to manufacture and market favipiravir in India. Among them are Dr Reddys, Strides Pharma, BDR Pharma and Optimus Pharma. Some of these companies are already exporting the drug to Turkey, Russia and Bangladesh.

Favipiravir, first brought out by a subsidiary of Fujifilm as ‘Avigan’ in 2014, gained attention in March this year after reports from China said it appeared to help in the recovery of Covid-19 patients with mild to moderate symptoms.

Last week, an observational study by Japan’s Fujita University said the effectiveness of the drug in treating Covid-19 remains inconclusive.

The researchers wrote that given over 80% of Covid-19 patients have mild symptoms, which often improve with supportive therapy, caution is required in interpreting the efficacy of favipiravir based on the data presented here. Although those who received the drug early on recovered faster than those who did not, the researchers also said that data was statistically insignificant to conclude that the drug is effective.

Jagadeesh Babu Rangisetty, CEO of Biosphore, said, “The results that were announced last week have remained inconclusive. What we are hearing from the countries where we are supplying this drug is that the drug has brought down hospitalisation in mild patients.” The export market for Favipiravir is pegged at $20mn

Biophore plans to boost manufacturing to 3 million tablets for India and the export market over the next two months. It is also in talks with universities in the US and Canada to supply the drug as part of a clinical trial that is expected to start in the coming months. ET has also learnt that companies such as Abbott, Macleods Pharma and Lupin, among others, are looking to launch their own brands of this drug in India.

Earlier this week, Glenmark Pharma announced a 27% cut in price for its brand of favipiravir—reducing it to Rs 75/tablet from Rs 103/tablet earlier. Glenmark said the price reduction had been made possible through benefits gained from higher yields and better scale, as both the API (active pharmaceutical ingredient) and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country.

Glenmark is also doing a trial of favipiravir in combination with another drug, Umifenovir, for hospitalised Covid-19 patients with moderate symptoms. It has also launched a post marketing surveillance (PMS) study on its brand of FabiFlu to closely monitor the efficacy and safety of the drug in 1,000 patients that are prescribed the oral antiviral. This is as part of an open label, multicentre, single-arm study.