Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, Biocon had earlier said in a regulatory filing.
Biotechnology major Biocon on Monday said it will launch biologic drug Itolizumab for the treatment of moderate to severe COVID-19 patients at a price of around 8,000 per vial. The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, Biocon had earlier said in a regulatory filing.
"Until the vaccine comes, we certainly need life saving drugs. I think what we are doing across the world is to see how we can either repurpose drugs or develop new drugs to treat this pandemic," Biocon Executive Chairperson Kiran Mazumdar-Shaw said in a virtual press conference.
Even if we get a vaccine by the end of this year or early next year, there is no guarantee that there will not be reinfection, there is no guarantee that it will work the way we expect it to work, so we must be in a state of preparedness, she added.
"When COVID happened, we said it actually gives us a very strong case to try it (Itolizumab) for COVID, because we do believe that the unique mechanism of action that it has can help us deal with this storm that we have seen is killing patients,'' Mazumdar-Shaw said.
Itolizumab is approved for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19, she added.
The cost of per vial is Rs 7,950. As most patients need 4 vials, the cost of the therapy is around Rs 32,000, Mazumdar-Shaw said.
On being asked if the company is ramping up the capacity to manufacture more vials on account of the pandemic, she said: "We have the manufacturing capacity and the supply and distribution network in place, however post this approval we are looking to ramp up production capacity to meet the expected surge in demand. Our aim is to reach a larger number of patients across the country".
The drug will be manufactured and formulated as an intravenous injection at the company's bio-manufacturing facility at Biocon Park, Bengaluru.
When asked about the steps the company is taking to ensure availability of the drug, Mazumdar-Shaw said: "Alzumab is already in market, we will be supplying to hospitals as per protocol against a medical prescription and patient consent form. Currently, there is a huge demand and Biocon wants to ensure Itolizumab first reaches those patients who need them the most".