New Delhi: The Drug Controller General of India (DCGI) has declined pharma giant Mylan’s request to waive clinical trials for blockbuster hepatitis C drug sofosbuvir on severe Covid-19 patients.
Sofosbuvir, which is used in combination with another low-cost hepatitis C drug, daclatasvir, has recently come under the spotlight for reducing the chances of death among patients hospitalised with Covid-19.
Mylan had presented the proposal to waive the Phase 3 clinical trial of sofosbuvir on the basis of “few Iranian studies”.
According to minutes of a 5 August meeting of the subject expert committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO), the apex body to regulate clinical trials in India, which is headed by the DCGI, “Firm presented their proposal before the committee requesting for a clinical trial waiver. The firm presented few Iranian studies conducted with the fixed dose combination (FDC) on moderate to severe patients,”
The minutes, uploaded on CDSCO’s website Thursday, stated, “Committee noted that this FDC is not approved anywhere in the world for use against novel coronavirus SARS-CoV-2.”
After detailed deliberation, “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 minutes stated.
What does the Iranian study show?
The Iranian study, based on three trials, was presented at the International AIDS Society Covid-19 scientific conference in July.
“One of these small trials was not randomised so the researchers… stress that the results should be seen as preliminary,” British daily The Telegraph said in a report on the presentation.
According to the scientists, 94 per cent of hospitalised Covid-19 patients who were given a combination of sofosbuvir and daclatasvir reported reduced fever and improved breathing, as against 70 per cent of those who did not get this drug combination.
The death rate for patients given this combination of drugs was 5 per cent, compared to 20 per cent for people on standard care, The Telegraph reported.
“We saw significantly faster rates of clinical recovery and hospital discharge for people taking the drug combination, and we also saw faster rates of survival,” said Dr Andrew Hill of Liverpool University, one of the researchers behind the study.
Other proposals discarded
Several other companies have approached the CDSCO with similar requests. At the same 5 August meeting, the CDSCO’s SEC discarded Gufic Biosciences’ proposal of trial waiver for Thymosin α-1 injection as an “add on treatment” in moderate to severe Covid-19 patients.
Thymosin is a polypeptide hormone, which forms a part of a protein molecule secreted by the thymus gland.
However, the committee felt the need for a phase 3 trial with a healthy sample size. “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,” the aforementioned minutes noted.
In its previous meeting, on 31 July, the SEC discarded drug maker Biosphere’s proposal to start phase 2 clinical trials on a drug molecule titled “PNB 001” for use on Covid-19 patients.
“The committee opined that the product is under early developmental stage as a non-specific anti-inflammatory agent, and data presented was inadequate for approval of the proposed Phase II clinical trial,” the minutes of that meeting stated.
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