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(Alliance News) - AstraZeneca PLC on Tuesday said its Tezspire and Koselugo drugs have been approved in Japan for the treatment of severe asthma and patients that suffer from a rare genetic condition, respectively.
The Cambridge, England-based pharmaceutical firm said Tezspire, whose generic name is tezepelumab, has been approved by the Japanese Ministry of Health, Labour & Welfare based on results from the Pathfinder clinical trial programme. Tezspire showed "superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy".
Executive Vice President for BioPharmaceuticals R&D Mene Pangalos said: "Tezspire is the first and only biologic approved by the Japanese Ministry of Health, Labour & 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. 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."
A biologic is any pharmaceutical drug product that slows or stops damaging inflammation, which is manufactured in or extracted from biological sources.
It came after Tezspire was approved in the EU last week. It has already been approved in the US and other countries for the treatment of severe asthma.
In a separate announcement, AstraZeneca said Koselugo, whose generic name is selumetinib, has also been approved by in Japan.
Koselugo is used to treat plexiform neurofibromas in neurofibromatosis type 1 that is found in paediatric patients three years of age and older.
NF1 is a genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene, affecting one in 3,000 people worldwide. Plexiform neurofibromas are tumours that grow along nerves.
AstraZeneca said the approval was based on positive results from the Sprint Stratum 1 Phase II trial, which showed Koselugo, an oral treatment option, reduced the size of inoperable tumours in children.
Trial investigator Yoshihiro Nishida, from the Nagoya University in Japan, said: "People living with plexiform neurofibromas caused by neurofibromatosis type 1 often face painful physical, emotional and social burdens. Koselugo provides a suitable intervention to treat symptomatic plexiform neurofibromas, which may improve long-term patient activities of daily living and quality of life."
AstraZeneca shares were down 0.6% at 9,875.00 pence each on Tuesday morning in London.
By Xindi Wei; xindiwei@alliancenews.com
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