Zydus Cadila applies for regulatory approval of Covid-19 drug

Zydus Cadila on Monday has declared that it has applied to the National Drugs Controller to get the approval for utilizing the viral hepatitis drug which is a part of phase 3 clinical trials and has shown promising results for treatment of Covid-19 patients.

As per the company, 91.15 per cent of the treatment were treated with Pegylated Interferon Alpha 2b, PegiHepTM were reverse transcription polymerase chain reaction (RT-PCR) negative by day seven, in comparison with 78.90 % on the standard of care arm for the phase three trials. The drug reduced the duration around supplemental oxygen to 56 hours from 84 hours in moderate of Covid-19 patients.

The company said in a statement, “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.”

The drug PegIFN has well defined safety with several doses in chronic hepatitis B and C over certain years. Aging takes down the capacity of the body to generate Interferon Alpha in response to viral infections and may be related to higher mortality in the aged patients. When given at the early stages of infection, the drug can satiate the deficiency and accelerate the faster recovery process. 

The patients who are on Pegylated Interferon Alpha 2b amid the trial showed lesser requirement for supplemental oxygen, pointing out that it has the ability to control respiratory distress and failure which is one of the key challenges for treating Covid-19.

The company stated, “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.”

The phase three trials have been done on a count of 250 patients throughout 20-25 centres in India, and the company is at the verge of publishing detailed results of the trials in a peer-reviewed scientific journal.

Sharvil Patel, Managing Director, Cadila Healthcare Ltd said, “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.”

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