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AstraZeneca's Selumetinib Receives the US FDA's Breakthrough Therapy Designation for Neurofibromatosis Type 1

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AstraZeneca's Selumetinib Receives the US FDA's Breakthrough Therapy Designation for Neurofibromatosis Type 1

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  • The BT Designation follows the P-II SPRINT trial assessing selumetinib as a monothx (PO) in paediatric patients- aged three years or older with inoperable NF1-related PN
  • The ninth BT designation is granted to the AstraZeneca for the MEK 1/2 inhibitor and the results will further lead to expedited regulatory review
  • Selumetinib is a MEK 1/2 inhibitor also received the US FDA’s ODD to treat NF1 in Feb 2018 and the European Medicines Agency in Aug 2018. In 2017- AstraZeneca and MSD signed a co-development and co-commercialization agreement for selumetinib

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Ref: AstraZeneca  | Image: AstraZeneca  


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