Glenmark says Phase 3 Favipiravir data for Covid-19 shows multiple benefits2 min read . Updated: 23 Nov 2020, 02:55 PM IST
- The pre-specified primary endpoint demonstrated a 2 day earlier virological cure in the Favipiravir treatment group, though not statistically significant, says Glenmark
Drug firm Glenmark Pharmaceuticals on Monday said as per a recently published data the oral antiviral medication Favipiravir was found to provide significant improvement in clinical cure in patients with mild to moderate Covid-19.
These findings were observed in a Phase 3 clinical trial conducted by Glenmark Pharmaceuticals and has been published by the globally reputed, peer reviewed International Journal of Infectious Diseases, the company said in a stock exchange filing.
The Phase 3 study with Favipiravir, sold under the brand name FabiFlu, by the company was conducted in 150 patients, it added.
"The study aimed to evaluate 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, randomized within a 48 hour window of testing RT-PCR positive for COVID-19," said the company.
Favipiravir was found to provide multiple treatment benefits, demonstrated by faster time to clinical cure, and significantly delayed the need for supportive oxygen therapy, Glenmark said.
"Additionally, patients of confirmed COVID-19 with moderate symptoms were discharged from hospital earlier than those patients that did not receive Favipiravir, with the median time to clinical cure reduced by 2.5 days compared with the control group," it added.
“Every claim for the efficacy of a new drug in COVID-19 must be backed by evidence from a clinical trial. Glenmark has done just that with Favipiravir. Their well-designed trial in 150 patients showed Favipiravir resulted in a significantly improved time to clinical cure and rapid viral clearance. Based on this I would consider the use of this anti-viral drug in sym tomatic patients with mild to moderate COVID-19. I eagerly await the results of similar trials presently being conducted in Boston and at Stanford," said Zarir F. Udwadia. MD, FRCP, FCCP, Breach Candy Hospital, Mumbai.
Favipiravir is an antiviral medication that works by inhibiting a viral enzyme called RdRP (RNA dependent RNA polymerase), thereby halting the virus's replication cycle. This helps control the multiplication of the virus and prevents its spread in the patient. Glenmark said.
"It is encouraging to see our trial results now published in a reputed global medical journal, which we hope will support other countries in their fight against this disease," Glenmark Pharmaceuticals Chief Commercial Officer Robert Crockart said.
In June 2020, the company had received manufacturing and marketing approval from India's drug regulator for its generic version of Favipiravir, for the treatment of mild to moderate COVID-19, Glenmark said.
"The pre-specified primary endpoint, time from randomisation to cessation of oral shedding of the SARS-CoV-2 virus, demonstrated a 2 day earlier virological cure in the Favipiravir treatment group, though not statistically significant. However, significant improvement in time to clinical cure and other secondary end-points suggest Favipiravir may be beneficial in the treatment of mild-to-moderate COVID-19," Glenmark said.