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Expert committee denies emergency approval for Zydus Cadila's HepC drug as COVID-19 treatment

Expert committee denies emergency approval for Zydus Cadila's HepC drug as COVID-19 treatment

Expert committee denies emergency approval for Zydus Cadila's HepC drug as COVID-19 treatment
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By Archana Shukla  Nov 5, 2020 11:53:13 PM IST (Updated)

Pegylated Interferon Alfa 2b injection, biological therapy is used for the treatment of Hepatitis B and C.

Drug regulator's subject expert committee has rejected Zydus Cadila's application for emergency use authorisation for its biological therapy, Pegylated Interferon alpha-2b or 'PegiHepTM' as a treatment of moderate COVID-19 patients. The rejection has come based on limited data and the small size of Phase 2 clinical trials.

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The company had submitted data from its Phase 2 clinical trial on 40 mild to moderately ill COVID-19 patients.
Pegylated Interferon Alfa 2b injection, biological therapy is used for the treatment of Hepatitis B and C. The drug is being seen as a potential treatment option for mild to moderate COVID-19 infection.
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In a randomised, controlled, open-label study, Zydus Cadila is investigating the efficacy and safety of the drug in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).
During the November 4 meeting, the subject expert committee in its response to Zydus Cadila's proposal said, "The firm presented the results of Phase II clinical trial and their proposal for grant of Emergency Use Authorisation for the treatment in moderate COVID-19 patients. The committee noted that the data was generated only in 40 patients. After detailed deliberation, the committee recommended that available data is not adequate for grant of permission for emergency use of the drug in COVID 19 patients." The minutes of the meeting were uploaded on the Central Drugs Standard Control Organisation (CDSCO) website.
Pegylated Interferon Alfa 2b emerged as a treatment option after two peer-reviewed research articles showed evidence of a direct anti-viral effect against novel coronavirus.
The first report published in the Journal of General Virology (June 2020) by researchers from Leiden University Medical Center, Netherlands. The second research by a group of universities in China, Australia, and Canada was published in Frontiers in Immunology (May 2020), showing a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6 on those patients who received Pegylated Interferon alpha.
Few countries like China and Cuba have experimented with Interferon alpha-2b in the treatment of COVID-19.
Zydus has been commercially manufacturing Pegylated Interferon alpha-2b under the brand name, PegiHep, since 2011 for the treatment of Hepatitis B and C with 1.5 lakh doses being administered, a company press note had stated. PegiHep is not yet licensed or approved for the treatment of COVID-19.
While multiple repurposed and new drugs are undergoing clinical trials as potential treatments across the globe, currently there are no approved therapies for the treatment of COVID-19.
The USFDA recently approved Gilead Sciences' drug Remdesivir as a COVID-19 treatment, however, the world is divided on its outcome. India has granted "emergency use authorisation" for few experimental drugs but has yet not approved any drug as proven COVID-19 treatment.
The subject expert committee had in its October 29 meeting rejected Dr. Reddy's proposal seeking to change the regulatory approval status for Remdesivir injection from "restricted emergency use" to "full marketing authorisation".
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