Glenmark Prescription drugs mentioned mixture of antivirals umifenovir and favipiravir within the therapy of average hospitalised Covid-19 sufferers didn’t present vital medical profit.
Giving particulars on its ‘Religion’ trial with the 2 medication, the corporate mentioned: “the examine confirmed no superior medical outcomes with the addition of umifenovir (to the therapy with favipiravir).”
This was the second examine undertaken by the drugmaker to judge the doable superiority of the mixture’s efficacy in opposition to favipiravir monotherapy. The Religion examine enrolled 158 hospitalised sufferers with average Covid-19 in India.
The primary trial involving Favipiravir and executed earlier this 12 months had led to the corporate receiving an “Emergency Use Authorisation” on the drug.
Time taken for remedy
The Religion trial’s main endpoint (medical consequence measured) was time taken from randomisation to medical remedy — outlined as decision of baseline medical indicators and signs of Covid-19 an infection and not less than a two-point enchancment on the WHO Ordinal Scale for Medical Enchancment — inside 28 days, the corporate mentioned. Median time to medical remedy improved by solely sooner or later in sufferers who acquired the two-antiviral mixture, which was not statistically vital and didn’t justify its use, they mentioned.
Monika Tandon, Glenmark’s Senior Vice President & Head, Medical Growth (World Specialty/Branded Portfolio) mentioned, “Glenmark was the primary firm to offer sufferers an oral antiviral therapy for COVID-19 in India, and this mixture examine was one more effort on our half to look at new therapy choices to fight the well being disaster. These newest findings verify that the addition of umifenovir doesn’t present any incremental profit in medical outcomes. Thus favipiravir remedy together with supportive care stays an appropriate and efficient alternative for delicate to average Covid-19 an infection.”
In June 2020, Glenmark grew to become the primary firm in India to obtain manufacturing and advertising approval for FabiFlu® as a part of accelerated approval course of.