Zydus Cadila seeks DCGI nod for use of hepatitis drug for COVID-19 treatment

PTI, Apr 5, 2021, 11:59 AM IST

New Delhi: Drug firm Zydus Cadila on Monday said it has sought approval from the domestic drug regulator Drugs Controller General of India (DCGI) for the additional indication of its hepatitis drug Pegylated Interferon Alpha-2b for treating COVID-19.

Phase-III clinical trials with Pegylated Interferon Alpha 2b, which the company sells under the brand name ”PegiHep” has shown promising results in treating COVID-19, Zydus Cadila said in a statement.

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, it added.

“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,” Zydus Cadila said.

PegIFN has very well-established safety with multiple doses in chronic Hepatitis B and C patients for many years, it added.

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.

“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.

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, the company 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,” Cadila Healthcare MD Sharvil Patel said.

With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone, he added.

Besides conducting a phase-II trial in Mexico, the company is also working with the United States Food and Drug Administration (USFDA) for Pegylated Interferon Alpha-2b in order to initiate appropriate clinical trials in the US, the company said.

Shares of Cadila Healthcare, the listed entity of Zydus Group, were trading at Rs 438.55 per scrip on BSE, down 0.75 per cent from its previous close.