AstraZeneca Welcomes Neurofibromatosis And Asthma Treatment Approvals in Japan
Japan has granted marketing approvals to AstraZeneca’s Kosulego (selumetinib) and Tezspire (tezepelumab), treatments for plexiform neurofibromas (PNs) in neurofibromatosis type 1 (NF1) and severe asthma respectively.
The approval of Kosulego, given by the Japanese Ministry of Health, Labor and Welfare (MHLW), makes it the first and only approved treatment for the treatment of children aged 3 years and older with PNs in NF1, a rare genetic condition that affects nerve tissue. Kosulego won US FDA approval for PNs in NF1 in April 2020, which was followed by a nod from the EU in June 2021. The drug is being developed as part of a massive $8.5 billion partnership between AstraZeneca and Merck (known outside the US and Canada as MSD).
The approval of Kosulego, given by the Japanese Ministry of Health, Labor and Welfare (MHLW), makes it the first and only approved treatment for the treatment of children aged 3 years and older with PNs in NF1, a rare genetic condition that affects nerve tissue. Kosulego won US FDA approval for PNs in NF1 in April 2020, which was followed by a nod from the EU in June 2021. The drug is being developed as part of a massive $8.5 billion partnership between AstraZeneca and Merck (known outside the US and Canada as MSD).
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