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DCGI Rejects Mylan’s Request to Waive Phase 3 Trials for COVID-19 Drug

DCGI Rejects Mylan’s Request to Waive Phase 3 Trials for COVID-19 Drug

Logo of Mylan Laboratories, a company primarily engaged in the commercialisation of generic drugs, pictured near Bordeaux, France, September 2019. Photo: Reuters/Regis Duvignau/Files.

New Delhi: The Drug Controller General of India (DCGI) has refused to grant permission for waiving phase 3 clinical trials for sofosbuvir, a drug used to treat hepatitis C, on patients suffering from severe COVID-19, according to The Print.

“The committee recommended that the firm should conduct a phase III clinical trial on Indian patients and accordingly phase III clinical trial protocol should be submitted for review by the committee,” the subject expert committee (SEC) at the Central Drugs Standard Control Organisation said in response to a request for waiver of clinical trials filed by the pharmaceutical company Mylan.

The DCGI recently came under fire from some members of the medical community after it waived phase III clinical trials for itolizumab, a known monoclonal antibody that Biocon Limited has repurposed to treat cytokine release syndrome in patients with severe COVID-19.

Mylan had asked for phase III human clinical trials to be waived arguing that studies in Iran have shown that sofosbuvir used in combination with another hepatitis C drug, called daclatasvir, lowered fever and improved breathing in 94% of hospitalised patients, versus 70% in the case of those who didn’t get the drug combination but the standard care.

The combination of drugs also reportedly reduced mortality, according to the studies, as the death rate in patients who had been administered the combination was 5%, versus 20% in the control arm.

However, one of the trials in the study was not randomised, so experts have said the studies should be treated with caution.

Also read: Is Biocon’s Itolizumab Good News? Hard to Tell, Thanks to the Bad Science.

The SEC, while adjudicating on Mylan’s request, said the firm should conduct a phase III clinical trial on patients in India following the protocol requirements and that those results should be submitted to the committee.

“The committee noted that this FDC [fixed dose combination] is not approved anywhere in the world for use against novel coronavirus SARS-CoV-2,” the minutes of the meeting said.

The committee also rejected the request of Gufic Biosciences for trial waiver for the use of thymosin α-1 injection as an “add-on treatment” in patients with severe or moderate COVID-19. “After detailed deliberation, the committee recommended that the firm should conduct phase III clinical trials.

Accordingly, firms should submit protocol with justified sample size for review by the committee.”

In the last week of July, Reuters reported that Mylan had “received Indian regulatory approval to make the tuberculosis treatment pretomanid available in a country that accounts for a quarter of the world’s cases.”

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