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

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Pharmaceutical Company Zydus Cadila on Monday informed that it has sought approval of the Drugs Controller General of India (DGCI) for using its hepatitis drug for the treatment of coronavirus.

This came after the third phase trials of the Pegylated Interferon Alpha 2b, PegiHep (PegIFN) showed promising results in treating the infection, the company said in a statement.

“In what could be a breakthrough in the disease management of COVID-19, the interim results indicate that PegIFN when administered early on, could help patients recover faster and avoiding much of the complications seen in the advanced stages of the disease, the company said in a media release.

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. 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 the 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 centers in India and the detailed results of this will be published in a peer-reviewed scientific journal.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said, “We are encouraged by the results of Phase III study of Pegylated Interferon alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease. At Zydus, we stand committed to our endeavour of supporting patients and caregivers with access to treatment options that are affordable and can help in better disease management of COVID 19 at different stages.” Cadila said that the company is also working with the US Food and Drug Administration (USFDA) for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the United States.

India had started COVID-19 vaccination drive was rolled out 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.