Approved by the Drug Controller General of India (DCGI) for restricted emergency use, Favipiravir marketed by Indian pharma major Glenmark as FabiFlu will be available at retail chemists and hospitals from next week onwards.

The drug is priced at ₹3,500 for a pack of 34 tablets (it is ₹103 per tablet). “It will be available in retail chemist stores and hospitals by next week, and patients will be able to access the drug with doctors’ prescription,” said Sujesh Vasudevan, President (India Formulations), Glenmark. 

Clinical trials showing early promising results

Glenmark has stated that it’s phase three clinical trials using antiviral drug Favipiravir for Covid-19 patients is showing early promising results. The DCGI has approved the drug for restricted emergency use, even as the results are yet to be declared. 

Monika Tandon, Vice President and Head, Clinical Development at Glenmark stated that up to 150 Covid-19 patients were enrolled in a randomized, multi-centric study at 11 sites in India, for evaluating efficacy and safety of Favipiravir. Of these, 90 were mild and 60 were moderate patients. This means that their conditions had not deteriorated to severe or critical stages of the disease. 

All the patients who were enrolled in the trial were hospitalised, and were treated with oral tablets of Favipiravir for two weeks at the most. Up to 3,600 mg or up to 18 tablets in dosage of 200 mg each were given to the patients on the first day. “From the second day onwards, a total of eight tablets, four in the morning and four in the evening, forming a total dosage of 1,600 mg were given,” Tandon explained. 

Most patients gradually recovered in a week, while other patients took almost two weeks to recover. The company is yet to publish the results of the clinical trial and did not disclose the number of patients that recovered, or if any succumbed while being a part of the trial. 

Earlier clinical trials around the globe on the drug include one in Russia, which enrolled 390 patients, and observed that within the fourth day of treatment, up to 68 per cent patients had no fever by the third day of getting Favipiravir, as compared to six days for fever resolution on supportive treatment. An observational study from Japan in 2,141 patients showed clinical improvement with Favipiravir up to 88 per cent within two weeks of treatment. 

Tandon said that the control arm of the trial against which the drug arm was compared was on supportive treatment in standard Covid-19 care including antibiotics, antipyretics, fluids and vitamins. “No Hydroxychloroquine was given to patients in the control arm. We have not used it as a standard of comparison against Favipiravir,” Tandon clarified.

Testing two anti-viral combination

Glenmark has also announced another clinical trial including 158 patients who will be divided into two groups. While one group will receive only Favipiravir the other group will receive a combination of Favipiravir and Umifenovir (another anti-viral). Tandon said, “A combination of two anti-virals may have a synergistic effect and lead to advanced efficacy. This will be the first trial ever to test the combination.”

Patients with severe kidney or liver disease, those having gout and pregnant or lactating women cannot take the drug, the company has warned. 

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