Favipiravir Shows Positive Results in Phase 3 Trials
What is favipiravir and what does the research say about its efficacy?
On Wednesday, 22 July, Glenmark Pharmaceuticals announced that the phase 3 clinical trials of their antiviral drug Favipiravir showed that it quickens recovery in mild-to-moderate COVID-19 patients.
The company released a statement saying,
“Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall 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 randomized multi-centric study was initiated in 150 mild to moderate patients in India to evaluate the efficacy and safety of the drug used with standard care in comparison to the group that received only supportive care.
FIT previously reported that on 20 June, Glenmark Pharmaceuticals launched antiviral drug Favipiravir for the treatment of mild-to-moderate COVID-19 cases after receiving ‘restricted emergency’ approval from the Drug Controller General of India to manufacture and market the medicine.
The company had claimed that Favipiravir shows clinical improvements of up to 88% in COVID-19 disease, with a rapid reduction in viral load by 4 days.
They had referred to four studies to substantiate the drug’s efficiency; A Russian clinical trial, an observational study in Japan on over 2,000 patients and two Chinese studies that compared it with antiretroviral drugs, finding it safer and faster in reducing time to relief than antiviral umifenovir.
Favipiravir is being studied in at least 18 trials around the world as a potential treatment for COVID-19. Glenmark had also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.
What is Favipiravir?
The antiviral drug Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It works by inhibiting viral replication and reducing the viral load in a patient.
It is an experimental medicine being repurposed for COVID-19.
The drug is not recommended in patients with severe renal, hepatic impairment, and in pregnant and lactating women.
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