New Delhi: The drug controller general of India (DCGI) has recommended the phase IV trial of Itolizumab by the Bengaluru-based Biocon Biologicals Limited.
The decision to allow phase IV trial of repurposed drug Itolizumab was given after the pharma company presented revised phase IV clinical trial protocol before the subject expert committee (SEC). Manufactured by Biocon, Itolizumab is being given to the Covid-19 patients for emergency purpose.
The subject expert committee has also asked Biocon to present safety and efficacy data of the new formulation of Itolizumab through 'IV' route of administration.
At the August 17 meeting, representatives from Biocon Biologicals Limited presented their proposal for the approval of new strength and new dosage form of the drug.
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"After detailed deliberations, the committee recommended that the firm should present the safety and efficacy data with the new formulations (Itolizumab 25 mg/5 ml solution for intravenous infusion in vial) before the committee," the SEC said.
Earlier, a Covid-19 task force recommended against the emergency use of Itolizumab, raising concerns over its efficacy. The apex drug regulator (DCGI) had earlier permitted Biocon to market the drug.
In a related development, the SEC has approved Bharat Biotech's proposal to conduct trials using intradermal (ID) vaccine delivery route. Bharat Biotech is currently doing human clinical trials of indigenous COVAXIN.
Through the ID process, the vaccine shot is given in the dermis, one of the layers of the skin. The shot is less invasive, requires lesser dosage and it also helps the vaccine show better immune response.
Read: Study Finds Why Some COVID-19 Patients May Not Develop Lasting Immunity
