AstraZeneca PLC (LON:AZN) said its Tezspire treatment has been approved in Japan for severe bronchial asthma where high-dose traditional corticosteroids don’t work.
It is the third approval in a matter of weeks for the product, a potential challenger to market leader Dupxient. It was developed in collaboration with US giant Amgen (NASDAQ:AMGN).
In clinical trials, the drug was shown to lower what the researchers called ‘asthma exacerbations’ by 56%.
"Tezspire is the first and only biologic approved by the Japanese Ministry of Health, Labour and Welfare that has been shown to consistently and significantly reduce attacks in exacerbation trials in a broad population of severe asthma patients irrespective of biomarker levels,” Mene Pangalos, head of biopharmaceutical research at AZ.
“Tezspire has the potential to improve outcomes for many patients with severe asthma and we are working to make this important medicine available in Japan as quickly as possible.”
Analysts believe Tezspire could be a big seller with peak sales projected to be in the order of US$2.5bn.