Coronavirus treatment: Kiran Mazumdar-Shaw-led Biocon has received approval from the Drugs Controller General of India for its drug Itolizumab for its use in moderate to severe COVID-19 patients.
Biocon on Saturday received approval from the Drugs Controller General of India (DCGI) for Itolizumab for its use in the treatment of moderate to severe COVID-19 patients in India. “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 hyperimmune response seen with COVID-19, said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, in a filing to BSE.
In an interview with CNBC, she said a similar trial done and data they received from trials is “encouraging”. According to her, as many as 150 patients have recovered already. I am confident that this ‘first-in-class’ biologic (Itolizumab) will save lives and help reduce the mortality rate in our country, she said.
Key things to know about Biocon’s Itolizumab:
1. Itolizumab will be used only for the treatment of patients with moderate to severe COVID-19 symptoms.
2. Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, according to a stock filing by the company.
3. The company has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as Alzumab for treating chronic plaque psoriasis, for the COVID-19 treatment.
4. The trials for Itolizumab were conducted at multiple hospitals, reportedly in four centres in Delhi and Mumbai. The study was focused on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe COVID-19 patients.
5. The drug will be manufactured and formulated as an intravenous injection at its bio-manufacturing facility at Biocon Park, Bangalore.
6. Itolizumab will cost Rs 7,950 for vial; the entire treatment, which will be hospital-based, would cost around Rs 35,000 per patient (infusion).
The whole world is reeling under the COVID-19 pandemic. India has reported as many as 878,254 coronavirus cases as of July 13; while 553,470 patients have recovered/discharged from hospitals, the country has seen 23,174 deaths due to the virus outbreak.