BENGALURU: Biocon suffered a setback on Sunday with the Union health ministry announcing that the firm’s itolizumab drug has not been included in national treatment protocol for Covid-19 patients.
Less than two weeks ago, the Drug Controller General of India had given permission for the drug’s use on moderate to severe coronavirus patients, leading to a surge in the company’s share price.
The health ministry in a note said the National Task Force on Covid-19 constituted by the ministry had held that there is “very less evidence in favour of this medicine.” Several independent experts had also questioned Biocon’s use of just 30 patients for the trial. But Biocon had noted that it is a drug that was approved previously for psoriasis, and this was only a label extension. It also said the emergency procedures for getting a clearance for use on Covid-19 patients were as per international norms.
On Sunday, following the ministry’s statement, Biocon said in a statement: “The National Covid Task Force needs to see more evidence and we will provide them large real world data to enable the committee to reconsider its decision on inclusion of itolizumab in the protocol. Nearly 1,000 patients have used the drug across the country with good outcome data.”
It went on to day: “Also, we have already announced that we have planned for a 200 patient pan India phase 4 trial to be conducted across 10-15 hospitals. The study protocol has been submitted to the DCGI and we will commence the trial soon.”