Glenmark Pharmaceuticals Ltd on Friday said addition of Umifenovir did not demonstrate any additional benefit over Favipiravir alone in moderate Covid-19 patients. Umifenovir did not show superior clinical outcomes when added to Favipiravir treatment, the trial did not meet key end-points, the company said.
The trial's findings confirm that the addition of Umifenovir does not show any incremental benefit in clinical outcomes, Monika Tandon, senior vice president & head, Clinical Development, Global Specialty/Branded Portfolio at the company, said in a statement , adding that favipiravir alone remains the effective choice for mild to moderate COVID-19 infection.
Favipiravir is made under the brand name Avigan by Japan's Fujifilm Holdings Corp and was approved for use as an anti-flu drug there in 2014, while Umifenovir is licensed as a treatment for some types of flu infections in Russia and China.
Fujifilm last month said a late-stage study of Avigan showed it reduced recovery times for COVID-19 patients with non-severe symptoms.
Mumbai-based Glenmark in July said its version of Favipiravir alone showed promise in a late-stage study of patients with mild to moderate coronavirus infection.
This was the second clinical study after the successful Favipiravir monotherapy trial earlier this year that led the company to receiving the Emergency Use Authorisation for Favipiravir.
This second study titled the FAITH trial evaluated the possible superiority of the combination’s efficacy against Favipiravir monotherapy.
The FAITH study enrolled a total of 158 hospitalized patients with moderate COVID-19 in India.
In June 2020, Glenmark became the first company in India to receive manufacturing and marketing approval for FabiFlu as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in the country.
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