Amid the controversy surrounding the pricing and efficacy of oral antiviral drug favipiravir, Glenmark announced the top line results of a phase-3 clinical trial of the drug in mild to moderate Covid-19 patients conducted across seven clinical sites in India. The results showed faster reduction in viral load as well as faster 'clinical cure' in patients.
The open-label multi-centre clinical trial, conducted on 150 patients, evaluated the efficacy and safety of Favipiravir plus standard supportive care (Favipiravir treatment arm), versus standard supportive care alone (control arm), in mild to moderate patients, randomised within a 48-hour window of testing RT-PCR positive for Covid-19. Favipiravir is a broad-spectrum oral antiviral that selectively inhibits the viral replication phase of SARS-Cov-2 virus.
Patients in the Glenmark Favipiravir clinical trial received Favipiravir tablets 3,600 mg (1,800 mg twice a day) on Day-1, followed by 1,600 mg (800 mg twice a day) for up to maximum of 14 days, along with standard supportive care. Around 90 patients were mild, while 60 were moderately sick.
Glenmark claimed that results of the phase-3 trial showed 'numerical improvements' for the primary efficacy end-point with 28.6 per cent faster viral clearance in the overall population. The key secondary outcome measures for clinical improvement demonstrated the efficacy and benefit of favipiravir treatment arm over the control arm, the company said in a statement. Favipiravir arm had 40 per cent faster 'clinical cure' as defined by the physician’s assessment of normalisation of clinical signs – temperature, oxygen saturation, respiratory rate and cough. The favipiravir arm had achievement of clinical cure in three days compared to five days in the control arm.
"Additionally, Glenmark’s Favipiravir was well tolerated with no serious adverse events (SAEs) or deaths in the Favipiravir treated arm," the statement said.
Glenmark plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks and share the findings.
Zarir Udwadia, one of the principal investigators of this study, commented: “The results of the Indian Favipiravir study are encouraging. The trial was performed with a sense of urgency considering the gravity of the pandemic, yet scientific principles were not sacrificed."
He added: "I have had a chance to independently view the initial results and they are encouraging: Patients randomised to Favipiravir seemed to have faster clinical cure, and more importantly, faster viral clearance than those randomised to the routine care group."
Glenmark launched FabiFlu in India on June 20. It has commenced a post-marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug on 1,000 patients who were prescribed with the oral antiviral, as part of an open-label, multi-centre, single-arm study. The company is also conducting another phase-3 clinical trial in India to evaluate the efficacy of two antiviral drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult Covid-19 patients.
The Drug Controller General of India had slapped a notice to the company asking it to clarify some points raised by a member of the Parliament on the pricing and efficacy of the drug. Glenmark had responded to the DCGI's letter on Tuesday.