Ahmedabad: Pharmaceutical major Zydus Cadila has sought the approval of the Drugs Controller General of India (DCGI) to use its biological drug Pegylated Interferon alpha-2b (PegIFN) for Covid-19 treatment.
Phase III clinical trials of PegIFN, which the company sells under the ‘PegiHep’ brand name, have shown promising results in treating Covid-19, the Ahmedabad-based group said on Monday.
Zydus said interim results indicate that the drug, when administered early during the course of infection, could help patients recover faster and avoid many 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,” the company said. “It would also ensure better compliance.”
For years, the drug has been safely taken by chronic hepatitis B and C patients. The drug has been repurposed for the treatment of Covid-19.
According to Zydus, patients on PegIFN also showed lesser need for supplemental oxygen during the clinical trial, indicating that it was able to control respiratory distress and failure. Respiratory problems have been among the major challenges in treating Covid-19. “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,” the company said.
“We are encouraged by the results of Phase III study which has confirmed the potential to reduce virus titres when given early in the disease,” said Sharvil Patel, MD, Cadila Healthcare Limited, the flagship company of Zydus Cadila Group. ‘Titre’ means concentration. Phase III trials of the drug were conducted on 250 patients across 20-25 centres in India and detailed results will be published in a peer-reviewed scientific journal, the company said. Besides conducting a Phase II trial in Mexico, the company is working with the United States Food and Drug Administration to initiate appropriate clinical trials for Pegylated Interferon alpha-2b in the US.