Drugmaker Zydus Cadila has applied to the Drugs Controller General of India (DCGI) seeking approval for additional indication for use of its Hepatitis C drug Pegylated Interferon alpha-2b in the treatment of COVID 19.
The application follows interim results from Phase III clinical trials that were promising, the company said on Monday. Sold under the brand PegiHep, Pegylated Interferon alpha-2b is being re-purposed for the treatment of COVID-19. It is a single dose regimen.
“The interim results indicate that when administered early on [the drug] could help patients recover faster and avoiding much of the complications seen in the advanced stages of the disease,” a release said. The Phase III trials were conducted on 250 patients across 20-25 centres in India and the detailed results will be published in a peer-reviewed scientific journal, it said.
Managing Director Sharvil Patel 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.”
Besides conducting a Phase 2 trial in Mexico, the company is also working with the USFDA to initiate appropriate clinical trials in the U.S.