Bangalore-headquartered Biocon may consider applying for full marketing authorisation for itolizumab, a novel antibody product used to treat Covid-19 patients, in India.
If the Drugs Controller General of India (DCGI) gives a nod for marketing authorization, itolizumab (brand name Alzumab) will become the first drug to have full authorization for use in Covid-19 patients. So far, repurposed drugs, such as Gilead’s remdesivir (an antiviral) or Roche’s tocilizumab (an antibody), have emergency use authorizations in different countries.
Arun Chandavarkar, managing director of the Bengaluru-headquartered company, said: “We expect results from the phase 4 study on itolizumab by the end of this quarter. This would be real-world data from around 300 patients.”
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