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Zydus Cadila seeks DCGI nod for use of PegiHep in Covid-19 treatment

Our Bureau Ahmedabad | Updated on April 05, 2021

Phase-3 clinical trials showed promising results in treating Covid-19

In what could be termed a major breakthrough in the disease management of Covid-19, drug major Cadila Healthcare Limited (Zydus Cadila) has said that initial Phase-III clinical trials of Pegylated Interferon Alpha 2b, PegiHep, showed promising results in the treatment of the novel coronavirus.

The interim results indicate that PegIFN, when administered early on, could help patients recover faster, avoiding many of the complications seen in the advanced stages of the disease.

Also read: Zydus Cadila cuts Remdesivir price to ₹899

The company has sought the Drugs Controller General of India’s approval for the use of Pegylated Interferon alpha-2b in treating Covid-19 in India. Pegylated Interferon alpha-2b, or PegiHepTM, is an approved drug in India and is being re-purposed for the treatment of Covid-19.

The initial Phase-III trial results showed that 91.15 per cent of patients treated with PegIFN were RT PCR negative by day 7 compared to 78.90 per cent on the standard of care (SOC) arm. 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. Pegylated Interferon Alpha 2b therapy has been well-established safety with multiple doses being administered in chronic hepatitis B and C patients since many years.

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. 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.

With these positive results, the company has applied for approval for additional indication with the DCGI for the use of PegIFN in the treatment of Covid-19, Zydus said in a statement on Monday.

Commenting on the feat, Sharvil Patel, Managing Director, Cadila Healthcare Ltd, said, “We are encouraged by the results of the Phase III 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.”

In December 2020, the company had received the drug regulator's nod to conduct Phase-3 clinical trials in Covid-19 patients for its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHep'.

The findings are in line with the recently reported importance of early IFN treatment given in combination with steroids in the treatment of Coid-19 (Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107, a Nature publication), the company said.

Type I interferons, including Interferon Alpha, have been found crucial in the protection against SARS-CoV-2, according to publications in leading journal Science (Hadjadj et al, Bastard et al and Zhang et al).

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.

Zydus is also conducting Phase 2 trials in Mexico, while it has also started discussions with the USFDA for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.

The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List.

Also read: Zydus Wellness targets B2C segment with its ghee brand

Zydus Cadila’s Pegylated Interferon alpha-2b, PegiHepTM, was originally approved for Hepatitis C and was launched in the Indian market in 2011. Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients and can be made readily available for the treatment of Covid-19.

Cadila Healthcare shares traded a marginal 0.7 per cent down on Monday at ₹438.

Published on April 05, 2021

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