Bengaluru-based Biocon Limited’s Itolizumab drug, used to treat Psoriasis, has got Drug Controller General of India's (DCGI) approval for restricted emergency use to treat coronavirus patients, the company said on Monday. The drug was given emergency use approval on the basis of clinical trials on just 30 patients.

Speaking about the development, Biocon's Executive Chairperson Kiran Mazumdar-Shaw that the apart from "compelling" trials, the drug has rescued 150 coronavirus patients in Maharashtra, Delhi and Gujarat. 

"As an innovation-led biopharmaceuticals company, I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper-immune response seen with COVID-19. The data is compelling and I am too confident that this 'first-in-class' biologic will save lives and help reduce the mortality rate in our country," she said.

 

The drug is already available in the market as Alzumab and costs Rs 8,000 per vial. According to Biocon, a patient typically needs four vials and the full course will cost Rs 32,000, which may not be affordable for many in the absence of government subsidy on the drug.

Biocon had started the randomised clinical trials of the drug as early as May. These trials were carried out at Delhi's All India Institute of Medical Sciences (AIIMS), Lok Nayak Jai Prakash Hospital, Mumbai's King Edward Memorial (KEM) Hospital and BYL Nair Hospital. 

 

Mumbai's Nanavati Hospital, where Bollywood megastar Amitabh Bacchan is undergoing coronavirus treatment, was also selected for the trials but the hospital reportedly failed to enroll any patient.

Posted By: Shashikant Sharma