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Large-scale clinical trials are wanting for key drugs Itolizumab and Tocilizumab as they have not yet been proven effective beyond doubt in reducing Covid-19 deaths. Itolizumab, used to treat Psoriasis skin condition, is marketed by Biocon, while Tocilizumab is a Roche product that is distributed by Cipla in India.
Balram Bhargava, Director General of the Indian Council of Medical Research (ICMR), said Itolizumab and Tocilizumab are being considered for averting a cytokine storm in Covid patients. A cytokine storm is the hyper-reaction of the immune system, which then starts attacking the patient’s own organs and can prove fatal.
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“There are two drugs which have been thought to prevent the cytokine storm. However, they have not yet demonstrated mortality reduction and therefore trials are wanting,” Bhargava said.
After Bhargava’s statement, Biocon’s founder Kiran Mazumdar Shaw tweeted, “Dr Bhargava is right. We have received Emergency Use Authorisation on a small pivotal trial. As mandated, we will do a larger Phase 4 clinical trial and we also have 150 patients real world ‘off label’ data which will be published.”
Emergency use
On July 11, the Drug Controller General of India (DCGI) granted approval for administering Itolizumab in Covid patients with moderate to severe acute respiratory distress under the clause of restricted emergency approval. Clinicians across India have used this drug ‘off label’ in at least 150 patients since May. Similarly, Tocilizumab is being used ‘off label’, meaning clinicians can prescribe these drugs after informed consent of patients, on ‘compassionate’ grounds.
On July 13, Biocon presented data of a clinical trial with a sample size of 30 Covid patients, of whom 20 were given Itolizumab. While those who took the drug survived, three ‘control’ patients died.
Experts criticised Biocon stating that the sample size used for the trial was small, and more evidence was required to prove the efficacy of the drug in reducing mortality. The company also came under scanner after the DCGI waived the need to conduct Phase 3 clinical trials (usually large-scale multi-centre trials), and allowed the company to post marketing surveillance, or Phase 4, data.
“On what basis has the Subject Expert Committee of DCGI waived the requirements for Phase 3 trials? I understand that safety data is available for Psoriasis (original condition) for this drug, but the disease model of Covid-19 is different. Phase 3 studies are for efficacy, not safety,” said Dinesh Thakur, a public health activist.
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