New Delhi: The Modi government’s expert panel has asked Indian drugmaker Biocon to monitor “efficacy of the drug” and not just the “safety” of its experimental Covid-19 drug, Itolizumab.
Biologic drug Itolizumab is a ‘humanised monoclonal antibody’, developed by Biocon in collaboration with the Centre for Molecular Immunology in Cuba.
While Itolizumab is an already approved drug used in treatment of skin ailment psoriasis, it was approved for “restricted emergency use” in the treatment of coronavirus by the apex regulator, the Drugs Controller General of India (DCGI), on 12 July.
Bengaluru-based drugmaker had last month presented the proposal for amendment to the already approved phase 4 clinical trial before the Subject Expert Committee (SEC).
The panel — which advises the DCGI on applications seeking approvals for new drugs, vaccines — recommended the company to change the “primary objective of the clinical trial” from monitoring safety of the drug to checking “efficacy” of the drug along with its safety.
“The firm should amend the primary objective to include clinical outcome efficacy assessment in addition to safety assessment as primary endpoint,” the SEC said at a meeting on 26 November, minutes of which were uploaded recently on the website of the Central Drugs Standard Control Organisation (CDSCO). The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country.
“Accordingly, the firm should submit the revised proposal for further consideration of the committee.”
Usually, the phase 4 trials are done as “post marketing surveillance” and is also known as “confirmatory trial”. Under this phase, the data on serious adverse reactions of the drug are noted and reported to the regulator.
The “efficacy” of the drug is generally established in phase 3 trials and not in phase 4. However, the DCGI had approved the drug without the mandatory phase 3 clinical trials in India. The move raised eyebrows among public health experts as phase 3 trials are deemed important for estimating the therapeutic efficacy of an experimental drug better.
Biocon’s spokesperson told ThePrint that “we will go by the advice and do the needful”.
Also read: All about Biocon’s Itolizumab, psoriasis drug approved for emergency use in Covid patients
Drug used on 2,000 Covid patients already
Itolizumab, which failed to impress the national Covid-19 task force for inclusion in clinical management protocols for treating coronavirus patients, has been given to “approximately 2,000 COVID-19 patients” under the emergency use authorisation, the company informed the panel.
The SEC has asked the firm to submit “safety data including the mortality data generated till date”. Mortality data reflects the efficacy of the drug in preventing the death due to Covid related illness.
In July, the company had announced plans to conduct a pan-India phase 4 trial, to be conducted on 200 patients across 10-15 hospitals.
“The results from the Phase 4 will create a larger body of evidence for efficacy of Itolizumab in Covid-19 complications,” the company said earlier.
Disclosure: Biocon founder Kiran Mazumdar Shaw is among the distinguished investors of ThePrint. Please click here for details on investors.
Also read: 30 patients, 2 months — how Biocon claims to have found a Covid hope in itolizumab