Amidst controversy over the pricing and efficacy of the generic oral antiviral drug favipiravir, Glenmark Pharmaceuticals announced the top line results from a Phase 3 clinical trial of the drug in mild to moderate Covid-19 patients conducted across seven clinical sites in India.
Glenmark claimed that 69.8 per cent of patients in the favipiravir treatment arm achieved ‘clinical cure’ by Day 4, which was statistically significant, compared to 44.9 per cent observed in the control arm.
The open-label, randomised, multicentre clinical trial, conducted on 150 patients, evaluated the efficacy and safety of favipiravir plus standard supportive care (favipiravir treatment arm) versus standard supportive care (control arm) in mild to moderate patients, randomised within a 48-hour window of testing reverse transcription polymerase chain reaction (RT-PCR) positive for Covid-19.
Favipiravir is a broad spectrum oral antiviral drug that selectively inhibits the viral replication phase of SARS-Cov-2 virus.
Patients in the Glenmark clinical trial received favipiravir tablets of 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 a fortnight, along with standard supportive care. Around 90 patients were mild, 60 were moderately sick.
Glenmark claimed the results from the Phase 3 trial showed ‘numerical improvements’ from the primary efficacy endpoint, 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 the favipiravir treatment arm over the control arm, the company said in a statement.
The favipiravir arm had 40 per cent faster ‘clinical cure’ as defined by a physician’s assessment of normalisation of clinical signs — temperature, oxygen saturation, respiratory rate, and cough.
“Additionally, Glenmark’s favipiravir was well tolerated with no serious adverse events 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.
Dr 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 study on FabiFlu to closely monitor the efficacy and safety of the drug in 1,000 patients prescribed with the oral antiviral as part of an open label, multicentre, single arm study.
The company is conducting another Phase 3 clinical trial in India to evaluate the efficacy of two antiviral drugs favipiravir and umifenovir as combination therapy in moderate hospitalised adult Covid-19 patients.
The Drug Controller General of India (DCGI) had served a notice on the company, asking it to clarify some points raised by a Member of Parliament on the pricing and efficacy of the drug. Glenmark had responded to the DCGI’s letter on Tuesday.
Shares of Glenmark settled at Rs 413.70 per scrip on the BSE, down 0.13 per cent from its previous close.