Zydus Cadila seeks regulatory approval for Covid-19 drug
Zydus Cadila on Monday announced it has sought national drugs controller’s approval for use of its viral hepatitis drug as its phase 3 clinical trials showed promising results in treating Covid-19 patients.
According to the company, 91.15% of patients treated with Pegylated Interferon Alpha 2b, PegiHepTM were reverse transcription polymerase chain reaction (RT-PCR) negative by day seven, as compared to 78.90% on the standard of care arm in its phase 3 trials. Also, the drug reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate Covid-19 patients.
“…the interim results indicate that PegIFN, when administered early on, could help patients recover faster avoiding much of the complications seen in the advanced stages of the disease. PegIFN in Covid-19 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. It would also ensure better compliance,” said the company in a statement.
The drug— PegIFN— has well-established safety with multiple doses in chronic hepatitis B and C patients over the years.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. If given early during infection, the drug can replace this deficiency and aid a faster recovery process.
Patients on Pegylated Interferon Alpha 2b during the trial also showed lesser need for supplemental oxygen, indicating that it was able to control respiratory distress and failure that has been one of the major challenges in treating Covid-19.
“The findings are in line with recently reported importance of early IFN treatment given in combination with steroids in the treatment of Covid-19 (Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107, a Nature publication. With these positive results, the company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of Covid-19,” said the company.
The Phase 3 trials were conducted on 250 patients across 20-25 centres in India, and the company is in the process of publishing detailed results of the trials in a peer-reviewed scientific journal.
“We are encouraged by the results of Phase 3 study of Pegylated Interferon alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease. With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone. 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,” said Sharvil Patel, managing director, Cadila Healthcare Ltd.
Besides conducting a Phase 2 trial in Mexico, the company is also working with the USFDA for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US.