HONG KONG – Mumbai, India-headquartered Glenmark Pharmaceuticals Ltd. has released statistically significant top-line results from a phase III trial showing that Fabiflu (favipiravir), an antiviral pyrazine RNA polymerase inhibitor, can treat cases of mild to moderate COVID-19 in four days.

Glenmark found that 69.8% of patients in the favipiravir treatment arm of the study achieved clinical cure by day four vs. 44.9% of participants achieving the measure by the same timepoint in the control arm.

The data from the trial also demonstrated numerical improvements for the primary efficacy endpoint, with 28.6% faster viral clearance in the overall study population, as measured by the median time until cessation of oral shedding of virus, in the favipiravir treatment arm compared to those in the control arm.

The open-label, randomized, multicenter clinical trial, was conducted on 150 patients at seven clinical sites in India. It evaluated the efficacy and safety of favipiravir plus standard supportive care vs. standard supportive care alone.

Patients in the trial received favipiravir tablets for up to a maximum of 14 days, along with standard supportive care.

“The results have helped further establish the safety and efficacy of Fabiflu to be used in the treatment of mild to moderate cases of COVID-19,” Glenmark’s spokesperson told BioWorld.

“Our focus from the beginning has been to introduce a medication to resolve India's COVID-19 health crisis, and all our efforts, energy and investments have been directed towards this endeavor. Our efforts are to ensure Fabiflu is accessible to all patients who need it.”

In a reversal of the usual order of events, Glenmark first gained approval from India's drug regulator to market Fabiflu for the treatment of mild to moderate COVID-19 on June 20, a month ahead of announcement of the phase III trial results. Though the pharma company did not divulge exact sales numbers, it indicated sales of have been favorable in India since its approval.

“Since its launch, we have received good response for Fabiflu along with positive feedback from a significant number of key opinion leaders (KOLs) across the country. Our primary focus since the beginning has always been to find a therapy solution to address India's COVID-19 burden,” said the company’s spokesperson.

“The results of the Indian Fabiflu study are encouraging. The trial was performed with a sense of urgency considering the gravity of the pandemic, yet scientific principles were not sacrificed. I have had a chance to independently view the initial results and they are encouraging,” said Zarir Udwadia, one of the principal investigators of this study.

“Patients randomized to Fabiflu seemed to have faster clinical cure, and more importantly, faster viral clearance than those randomized to the routine care group. I eagerly await the final analysis and results from other ongoing studies from across the globe. Till then, I feel we have enough evidence to consider using Fabiflu in symptomatic COVID-19 patients who have mild to moderate infections.”

Glenmark is considering using the results to gain market authorization in other countries.

“Glenmark will certainly export Fabiflu to other countries if we get all the required approvals in place. We are well equipped to meet the urgent health needs of India and the world,” the company spokesperson said.

Monika Tandon, Glenmark’s head of clinical development for its global specialty and branded portfolio, said the company was encouraged by the top-line results.

“These (results) indicate that early treatment with Fabiflu may improve clinical outcomes for mild to moderate patients and could potentially prevent patients from progressing to acute respiratory distress syndrome and mortality,” said Tandon.

Glenmark initially priced Fabiflu at INR103 (US$1.38) per tablet in India. Then in mid-July, it reduced the price by 27% to INR 75 per tablet. The company said the price reduction has been made possible through “benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country.”

Many are expecting more approvals of generic favipiravir in India soon.

Indian companies Cipla Ltd., Lupin Ltd., Strides Pharma Science Ltd., Brinton Pharmaceuticals Ltd., Optimus Pharma Pvt. Ltd. and Lasa Supergenerics Ltd. have all sought regulatory approval in India to launch their respective brands of favipiravir.

"During this COVID-19 outbreak, each country is making decisions in line with its own public health requirements. We can expect more approvals of generic favipiravir in India. It will also increase drug access and make the pricing competitive,” said Prashant Khadayate, pharma analyst at Globaldata. “Moreover, the majority of the COVID-19 patients fall in mild to moderate stage and favipiravir can be termed as a drug for the masses amid the COVID-19 outbreak,” he said.