Zydus Cadila seek DGCI approval for ‘breakthrough’ Covid drug

Drug firm Zydus Cadila on Monday announced that it is seeking approval for additional indication with drug regulator DCGI for the use of its hepatitis drug Pegylated Interferon Alpha-2b for treating Covid-19. According to the pharma company, Phase-III clinical trials with Pegylated Interferon Alpha 2b, which company sells under the brand name ‘PegiHep’ has shown promising results in treating Covid-19. In what could be a major breakthrough in terms of covid treatment, the interim results indicate that the drug when administered early on, could help patients recover faster and avoid much of the complications seen in the advanced stages of the disease.

“The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single dose regimen. It would also ensure better compliance. PegIFN has very well-established safety with multiple doses in chronic Hepatitis B and C patients since many years. Patients on Pegylated Interferon Alpha 2b during the trial also showed 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 statement said.

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, it said.

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91.15% of patients treated with PegIFN were RT PCR negative by day 7 as compared to 78.90% on the standard of care (SOC) arm. “With these positive results, the company has applied for an approval for additional indication with DCGI for the use of PegIFN in the treatment of COVID 19,” it added.