Biotechnology firm Biocon on Friday said its arm Biocon Biologics and Viatris have received approval from European Commission for their product Kixelle, indicated for the treatment of diabetes. In a regulatory filing, Biocon Biologics informed that Kixelle – co-developed with Viatris Inc had received marketing authorisation approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations, the company added. The centralised marketing authorisation granted by the European Commission is valid in all European Union member states as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
Shares of Biocon were trading 0.04 per cent lower at Rs 406.60 apiece on BSE.