Zydus Cadila’s Antiviral Drug Gets Emergency Use Nod
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The Drug Controller General of India (DCGI) on April 23 granted emergency use approval for pharma major Zydus Cadila’s antiviral drug ‘Virafin’, to treat moderate COVID-19 disease in adults. A single-dose subcutaneous regimen will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications. Virafin will be available on the prescription of a medical specialist for use in hospital/institutional setup.

The drug’s safety profile is already well known as it is used in treating people with chronic hepatitis B and C. The drug has been repurposed for treating moderate COVID-19 disease. According to Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited, the therapy significantly reduces viral load when given early on and can help in better disease management.

In a multi-center trial in 20-25 centers across India, the company found the drug reduced the need for supplemental oxygen. In the phase-3 trials, the drug was able to achieve “better clinical improvement in the patients suffering from COVID-19”. A “higher proportion (91.15%) of patients administered the drug were RT-PCR negative by day seven as it ensures faster viral clearance”.

According to an April 5 company press release, the drug reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients. The results of the phase-2 trial using the drug found that of the 20 participants who received the drug and standard of care, 19 achieved clinical improvement on day 15 compared to 13 of the 20 participants who were in the control arm and received only standard of care.

The trial found that 80% and 95% of participants who received the therapy plus standard of care were RT-PCR negative on day seven and 14, respectively, compared to 63% and 68% in the control arm. The significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to the control arm. Participants with the moderate disease showed a difference as early as day seven, which became significant by day 14. Mild adverse events were reported in 11 participants in the phase-2 trial compared with eight in the control arm.

According to the release, type I interferons are the body’s first line of defense against many viral infections. In old people, the ability to produce interferon-alpha in response to viral infections gets reduced, which might be the reason for higher mortality. The drug when administered early during the disease can replace this deficiency and help in the recovery process.

Source:
https://www.thehindu.com/sci-tech/health/zydus-cadilas-antiviral-drug-gets-emergency-use-nod/article34392919.ece
H●●●l S●●h and 32 others like this25 shares
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Dr. H●●●●●j P●●●l
Dr. H●●●●●j P●●●l General Medicine
Good news.
Apr 26, 2021Like
Dr. H●●●●●j P●●●l
Dr. H●●●●●j P●●●l General Medicine
Good news.
Apr 26, 2021Like
Dr. S●●●●p N●●h
Dr. S●●●●p N●●h Internal Medicine
How authentic are the study results and how pharma driven these results are...that' s the major question..
May 5, 2021Like