The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has asked Biocon Biologics to submit safety data of Itolizumab injection, including mortality data which has been generated till date.
The SEC will examine the COVID-19 related proposal which is under the accelerated approval process.
In the SEC meeting, held on November 26, 2020, the committee informed that the company has submitted a proposal for amendment of the already approved phase IV Clinical trial. The objective is to evaluate the safety and efficacy of Itolizumab, dosage of 25 mg/5 ml solution for intravenous infusion in vials.
“After detailed deliberation, the committee recommended that the firm should amend the primary objective to include clinical outcome efficacy assessment in addition to safety assessment as the primary endpoint. And should also submit the justification for the proposed amendments. Accordingly, the firm should submit the revised proposal for further consideration of the committee,” said the SEC in a statement.
After the DCGI granted emergency use authorisation for the drug in July, patient groups had sought clarifications from the authority and raised concerns over the drug’s clinical trial procedures. Later, in August, the DCGI instructed the company to revise its clinical trial protocol for conducting phase- IV studies on Itolizumab.
The company informed to the committee (SEC) that approximately 2000 COVID-19 patients have been used the drug under the emergency use authorisation.
On this, the SEC recommend to the company that they should submit safety data including the mortality data generated till date.
Prof Bejon Misra, Founder Director, Patients Safety and Access Initiative commented, “As a patient group representative, I do not like to compromise on drug quality as well as on the standard operating procedures (SOPs) of clinical trials. However, in the time of an emergency, certain well-established procedures need to be understood and reaffirmed in terms of patient safety and quality before the regulators allow such products to be brought into the public domain.”
When reached out to the company, a spokesperson commented, “We go by the regulators’ advice and will do the needful as requested.”