NEW DELHI: Drug firm Zydus Cadila on Friday said it has received restricted emergency use approval from the Indian drug regulator for the use of Pegylated Interferon alpha-2b (PegIFN) in treating moderate Covid-19 infection in adults.
Earlier in the month, the company had sought approval from the DCGI for the additional indication of hepatitis drug Pegylated Interferon Alpha-2b for treating Covid-19.
The company has received restricted emergency use approval from the Drug Controller General of India (DCGI) for the use of Virafin , PegIFN in treating moderate Covid-19 infection in adults, Zydus Cadila said in a regulatory filing.
PegIFN has very well-established safety with multiple doses in chronic Hepatitis B and C patients for many years.
Synopsis
When administered early on during Covid, Virafin will help patients recover faster and avoid much of the complications, the company said in a statement.
Zydus Cadila gets emergency nod to market anti-arrhythmic drug for treating moderate Covid-19
Pharma company Zydus Cadila today received restricted Emergency use approval from India’s drug regulator for the use of Virafin, Pegylated Interferon alpha-2b (PegIFN) in treating moderate Covid-19 infection in adults.
When administered early on during Covid, Virafin will help patients recover faster and avoid much of the complications, the company said in a statement.
Virafin will be available on the prescription of medical specialist for use in hospitals.
Zydus Cadila seeks DCGI nod for use of PegiHep in Covid-19 treatment
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.
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.
Zydus COVID-19 drug shows promise in Phase 3 trials; seeks DCGI nod
Over 91.15% of patients treated with PegIFN were found to be RT PCR negative by day 7 as compared to 78.90 per cent on the standard of care arm; PegIFN reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients
BusinessToday.In | April 5, 2021 | Updated 12:51 IST
Interim results show PegIFN could help patients recover faster, avoiding complications seen in the advanced stages
Zydus Cadila announced on Monday, April 5 that it has sought approval from drug regulator DCGI (Drugs Controller General of India) for its drug Pegylated Interferon Alpha 2b (PegIFN) to be used in the treatment of COVID-19 patients. The domestic pharma company has applied for an approval for additional indication with DCGI for the use of PegIFN, announcing that its phase-III clinical trials with the drug have manifested promising results in treating coronavirus patients.