New Delhi: The Modi government’s panel of experts has rejected a request by the American pharma giant Mylan for a second time. The company had sought approvals for conducting a phase 3 trial using blockbuster hepatitis C drug, Sofosbuvir for Covid patients.
In August, the subject expert committee (SEC) had rejected the company’s request to waive clinical trials for the drug. The company had proposed to study the impact of the drug combination of low-cost hepatitis C drug Daclatasvir along with Sofosbuvir.
Instead of a phase 3 trial, the SEC has recommended Mylan conduct phase 2 trials. It also highlighted, again, the discrepancies in the Iranian studies submitted by the firm as a part of its application.
“It will not be desirable to have a direct Phase III trial just based on two Iranian studies which were just investigator initiated studies and not approved by Iranian, Food and Drug Administration,” the panel recommended, according to the minutes of the meeting uploaded on the the website of the Central Drugs Standard Control Organisation (CDSCO), the health ministry arm that regulates the quality of drugs and vaccines in the country.
The SEC advises the Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials for Covid-19. The DCGI is the country’s apex body to approve clinical trials in India.
In a meeting held on 14 September, the panel recommended that “it will be appropriate to conduct phase II trial on moderated COVID-19 patients with the proposed design in place of Phase III trial”.
The Iranian studies had shown that 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.
‘Sample size for trials not justified’
The panel, according to the minutes, showed dissatisfaction over the proposed sample size for conducting phase 3 trials.
“Firm could not provide statistical justification for the sample size of 268 subjects for conducting the proposed Phase III clinical trial,” it said while adding that “it will not be appropriate to include mild patients in the proposed study.”
The panel further said “the fixed dose combination of daclatasvir + sofosbuvir is also not approved internationally for the treatment of COVID-19 patients”.
The panel has asked the company to further deliberate and address the points raised the SEC.
Earlier proposal rejected
Mylan had earlier asked that for the waiver of the phase 3 clinical trial of Sofosbuvir on the basis of “few Iranian studies”.
In a meeting on 5 August, according to its minutes, 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 committee had then recommended that the firm conduct a phase 3 clinical trial on Indian patients and accordingly submit clinical trial protocol for review by the committee.
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