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.
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Zydus Cadila seeks DCGI nod for use of hepatitis drug for COVID-19 treatment
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.
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.
With the phase-3 clinical trials of its Pegylated Interferon Alpha 2b therapy, PegiHep, showing promising results, Cadila Healthcare Ltd (Zydus Cadila) has applied for an approval for additional indication with the Drugs Controller General of India (DCGI) for the use of PegIFN in the treatment of Covid-19. In what could be a breakthrough in the disease management of Covid-19, the interim results indicate that PegIFN when administered early on, could help patients recover faster and avoid much of the complications seen in the advanced stages of the disease. According to Zydus Cadila, PegIFN in Covid-19 has several add-on advantages compared to other anti-viral agents with the treatment regimen being less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single dose regimen.
Fund support from government is vital for continual treatment of those with rare diseases
It is binding on a welfare state to take care of every single citizen. Securing the wellbeing of every one, particularly those unable to help themselves, irrespective of whether they constitute a critical mass or not, is important. The recent notification of the National Policy for Rare Diseases 2021 after various interventions, including the court, is pegged on this principle of inclusion. A good start, it offers financial support for one-time treatment of up to ₹20 lakh, introduces a crowdfunding mechanism, creates a registry of rare diseases, and provides for early detection. In its final form, however, the policy has left the rare diseases lobby sorely disappointed on a crucial note. Rare diseases are broadly defined as diseases that infrequently occur in a population, and three markers are used the total number of people with the disease, its prevalence, and the availability/non-avail