Drug regulator DCGI waives off Phase-III trials for Biocon’s drug

Indian drug regulators have exempted Bengaluru-based biotechnology major Biocon from carrying out the Phase-III clinical trial of its drug itolizumab that has been repurposed to treat Covid-19 patients in hospitals.

Last Friday, a subject expert committee at the Central Drug Standards and Control Organisation recommended waiving off the phase-3 clinical trial for the Biocon drug on the basis of a Phase-II trial on 30 patients.

Originally developed for treating psoriasis, the drug has been repurposed for Covid-19 as it has the ability to battle the cytokine storm (severe immune reaction) inside the body caused by the novel coronavirus.

The CDSCO panel recommended use of the drug in “moderate to severe” acute respiratory distress syndrome (ARDS) patients due to Covid-19, whereas the company in a press statement said the therapy was approved by the Drugs Controller General of India for “restricted emergency use” in India. The composition of the committee is not publicly known.

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The regulatory panel asked the company to carry out phase-IV clinical trials (post-marketing surveillance) besides submitting the risk management plan to the DCGI to address safety issues and informed consent. The decision, however, raised concerns with some of the medical researchers questioning the regulator on the waive-off.

“We should have details on what basis such decisions are made. It should not be sufficient to say ‘After detailed deliberation, the committee recommended for grant of permission to market the drug for Restricted Emergency Use.’ The SEC should lay out the substantive deliberations which went into making the assessment. Skipping Phase-III trial given small numbers in Phase-II does raise concerns,” Anant Bhan, researcher, global health, bioethics and health policy and past president of the International Association of Bioethics told DH.

The treatment costs Rs 32,000 as one vial costs Rs 8,000 and four vials are needed for the treatment, according to a Biocon spokesperson.

In the trial conducted at four hospitals in Mumbai and Delhi, 20 patients received the medicine while the remaining 10 received the standard care. All 20 patients on the drug arm recovered fully and were discharged, but three out of 10 patients in the control arm died.

In a statement, Biocon’s executive chairman Kiran Mazumdar-Shaw said, “As we are in the middle of a medical emergency, we went ahead with a pivotal clinical trial involving a cohort of 30 patients. The two-arm, randomized study met both the primary and secondary endpoints, with the Itolizumab arm demonstrating statistically significant advantage over the control arm, culminating in the drug’s approval for restricted emergency use by the DCGI.”

These results are in line with findings from a similar clinical trial in Cuba, where 76 Covid-19 patients were treated with Itolizumab. At the end of the trial, 79% of severely ill patients were discharged from the ICU after 14 days of treatment, while moderately ill patients showed a reduction in the rate of disease progression.

“The DCGI’s approval for restricted emergency use of Itolizumab to treat Covid-19 patients with moderate to severe complications is timely as it will urgently provide physicians and patients with a new treatment option at a time when novel coronavirus infections are surging in India,” Biocon said in the statement.