Biotechnology firm Biocon has received marketing approval from the Drugs Controller General of India (DCGI) for the drug Itolizumab. The drug marketed under the brand name AlzumabTM is indicated for the treatment of psoriasis. It will be manufactured and formulated at Biocon Park, Bangalore.
The drug will be launched only in the latter half of calendar year 2013 and will see revenues coming in only two years after the launch, analysts said. According to Bhavin Shah, analyst, Dolat Capital, the product is for a niche indication and it will take time for doctors to start prescribing the product. During the 52 week Phase III multi-centric clinical study conducted in India Itolizumab showed outstanding safety profile.
‘We are very excited to receive this marketing authorization for Itolizumab from DCGI which will enable Biocon to introduce this novel, first in class biologic for the treatment of psoriasis patients in India. This approval paves the way for us to extend clinical development for other indications like Rheumatoid Arthritis (RA), Multiple Sclerosis (MS) and Vitiligo,’ Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon was quoted as saying by TOI. To get clearance to do more human trials of the drug, the company aims to file an investigational new drug application with the US Food and Drug Administration.