Zydus Cadila gets DCGI nod for using its hepatitis drug for COVID-19 treatment

Hyderabad: India's drug regulator has granted permission for use of the pharmaceutical company 'Zydus Cadila' hepatitis drug for the treatment of coronavirus. The approval by the Drugs Controller General of India (DCGI) comes after the third phase trials of the Pegylated Interferon Alpha 2b, PegiHep (PegIFN) showed promising results in treating the infection. A release by Cadila Health said, "The drug has also shown efficacy against other viral infections." 

According to the pharmaceutical company, 91.15 per cent of patients treated with PegIFN were RT PCR negative by Day 7 as compared to 78.90 per cent on the standard of care (SOC) arm. 

Speaking on the development, Dr Sharvil Patel, Managing Director, Cadila Healthcare Limited said: "The fact that we are able to offer a therapy which significantly reduces viral load when given early on can help in better disease management. It comes at a much-needed time for patients and we will continue to provide them access to critical therapies in this battle against COVID-19."

The company claims that PegIFN reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients. A single dose administered early on shows high clinical improvement in patients. PegIFN in COVID19 has several add-on advantages compared to other anti-viral agents. 

The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single-dose regimen, the press release reads. 

It further said that PegIFN has very well-established safety with multiple doses in chronic hepatitis B and C patients for many years. Patients on Pegylated Interferon Alpha 2b during the trial also showed a lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19.

The findings are in line with the recently reported importance of early IFN treatment given in combination with steroids in the treatment of COVID-19.

Aging reduces the body's ability to produce Interferon Alpha in response to viral infections and may be associated with higher mortality in elderly patients.

Pegylated Interferon Alpha 2b given early during infection can replace this deficiency and aid a faster recovery process. The Phase III trials were conducted on 250 patients across 20-25 centres in India and the detailed results of this will be published in a peer-reviewed scientific journal. 

India had started COVID-19 vaccination drive on January 16 with two vaccines -- Covishield (Oxford-AstraZeneca's vaccine manufactured by Serum Institute of India) and Covaxin (manufactured by Bharat Biotech Limited). 

India commenced its second phase of the COVID-19 vaccination drive to inoculate people above 60 years and those over 45 with comorbidities against the coronavirus from March 1. The third phase began on April 1 for all above 45 years of age and the fourth phase will commence on May 1.

Meanwhile, India recorded 3,32,730 new COVID-19 cases in the last 24 hours, the highest single-day spike since the pandemic broke out last year. India has crossed the mark of 3 lakh COVID-19 cases for two consecutive days now. 

This has taken the cumulative count of the COVID infection in the country to 1,62,63,695. According to the official data issued by the Union Health Ministry, the country has recorded 2,263 new deaths due to COVID-19 in the last 24 hours. As many as 1,86,920 people have succumbed to the viral infection in India so far. 

There are 24,28,616 active COVID-19 cases in the country now. As many as 1,36,48,159 recoveries have been reported so far, out of which 1,93,279 were reported in the last 24 hours.

(With inputs from agencies)